Month: March 2022

Cleaning of Vacuum Cleaner

March 31, 2022February 6, 2023 ABHA

Cleaning of Vacuum Cleaner

Objective

To lay down a procedure for the cleaning of Vacuum Cleaner.

Scope

This SOP is applicable for cleaning of Vacuum Cleaner to warehouse of formulation plant

Responsibility

Operator / Technician – For cleaning of Vacuum Cleaner.
Warehouse personnel– For checking the cleanliness of the equipment.

Accountability

Department Head/incharge & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

QA : Quality Assurance
WH : Warehouse
RM : Raw Material
SOP : Standard Operating Procedure

Procedure

Procedure for cleaning of Vacuum Cleaner

Switch OFF the vacuum cleaner.
Remove “Status” label and affix ‘To be cleaned’ label.
Dismantle the parts (cover with gasket, Hose pipe and Filter bag) and take it to equipment wash room.
Remove the Powder collected in Filter bag in poly bag and destroy as per SOP.
Mop the vacuum cleaner with wet duster then with dry duster.
Mop the dismantled parts and body of vacuum cleaner using wet dusters then with dry duster except filter bag.
Assemble the dismantled parts to vacuum cleaner.
Remove “TO BE CLEANED” label and affix the “CLEANED” label.

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Forms and Records (Annexures)

Not Applicable.

Distribution

Master copy – Quality Assurance
Controlled copies – Quality Assurance, Raw Material Store.

History

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SOPs

Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of Rubber Stereo

March 30, 2022February 6, 2023 ABHA

Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of Rubber Stereo

Objective

To lay down a procedure for Inventory, Storage, Issuance, Withdrawal, Destruction, and Reconciliation of Rubber stereos used on packing / overprinting machines.

Scope

This SOP is applicable for placing orders, receiving, checking of impression, issuance, usage, withdrawal, and destruction of rubber stereos used for all packing / overprinting machines at pharma industries.

Responsibility

Production Operator/ Technician/Printing In-charge shall be responsible for following the procedure mentioned in the SOP.
Production Officer/ above shall ensure the proper usage, withdrawal, and destruction of rubber stereos used on all packing/ overprinting machines.
Head & QA Personnel shall be responsible for proper compliance of SOP.

Accountability

Department Head and QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

QA: Quality Assurance
BMR: Batch Manufacturing Record

Procedure

Order, Receipt & Issuance of Stereos

As per the production planning, the order of the required stereos should be placed to the party by Printing In-charge duly checked by the Production Officer and verified by QA Personnel as per Annexure-I. The details shall be overprinted with the proper instructions regarding the type of stereos, stereo size and the quantity shall be mentioned with instructions.
Every stereo record shall have a serial number as described below: MMM/XXX/YY, where, MMM means the first three letters of the current month e.g. Sep for September, XXX means serial number e.g., 001,002,003 and so on…, and YY means last two digits of the current year e.g., for 2014 it would be 14 and so on…
The number of stereos shall be ordered as per printing requirement and quantity shall be mentioned in Annexure-III.
After receiving the stereos, printing In-charge personnel shall check whether these are as per Stereo Order and shall check the delivery challan.
Printing Operator shall take the stereo impression which shall be checked by printing In-charge and counter checked by production and further verified by QA as per Annexure-II.
If the impression of stereo is not clear or any type of discrepancy is observed then the respective stereo shall be destroyed by responsible Production Personnel in presence of QA personnel.
Impression of the next stereo shall be taken as per Annexure-II. The previous impression shall be diagonally cut and signed by printing In-charge.
If rejection of impression shall repeat
After completion of impression printing In-charge shall hand over the stereos to Production Department. Production personnel shall enter the details in Annexure-III.
Production personnel shall keep the stereos in the designated area under lock & key.

Issuance of Stereos:

In case of printing of outer carton, inner carton and label stereo shall be issued to printing In-charge by responsible production personnel in presence of QA personnel as per Annexure-III.
In the case of foil, stereo shall be issued to individual section heads by responsible production personnel in presence of QA personnel as per Annexure-III.

Usages of Stereos:

After setting a standard number of stereos on the packing / overprinting machine, the operator shall give the impression of the stereos on foil/cartons/label, etc. for checking by the Production and verified by QA Personnel. (In case of carton/label Printing In-charge and Quality Control Personnel shall also check the impression).
After verifying the impressions, a sample of verified impressions duly signed by concerned personnel shall be attached as a specimen to the BMR. This specimen is known as ‘Initial Proof’.
After verification processing of batch shall be started.
During the batch run, if any stereo or the full set of stereos shall change
After completion of the batch, the operator shall take the impression of the stereos on foil/cartons/label. This impression shall be verified by Production Personnel and counter-checked by QA Personnel. This is kept in the BMR as the ‘Final Proof.
After verification of the completed batch, all the used stereos shall be handed over to the responsible Production Personnel.

Withdrawal of Stereos:

If the batch is suspended halfway, the final specimen of the impression shall be maintained with BMR and stereo shall be handed over to responsible production personnel before packing of the next batch. Preserve the stereos of the suspended batch in lock & key and subsequently shall be re-issued from responsible production personnel as per Annexure-III, when the remaining quantity of suspended batch is to be packed.
Take the line clearance from QA Personnel before packing of remaining quantity of the suspended batch.
Production Officer shall check the initial proof of stereo impression and counter-checked by QA Personnel before starting the packing of remaining quantity of suspended batch.
Meanwhile, coding/ printing, if the stereo gets a smudge or damage the same, shall be replaced by reissuing a new one and the proof shall be again checked by Production and QA personnel. Record the re-issuance in Annexure-III.
Stereo shall be withdrawn after cleaning by using thinner.
The exact number of stereos shall be returned by operator/ Printing In-charge and withdrawn by production personnel as per Annexure-III.
Withdrawal of stereo shall be done in presence of QA personnel.

Destruction of Stereos:

Ensure that after the usage of the stereos of the previous batch/product is removed and handed over to Production personnel in presence of QA personnel as per annexure-III.
Production Personnel shall destroy the used stereos in presence of QA personnel by cutting them into pieces across the letters using scissors and disposing of the destructed stereo to scrap room in a polythene bag.
Destruction details shall be recorded in Annexure-III.

Forms and Records (Annexures)

Stereo Order – Annexure-I
Stereo Checking Record – Annexure-II
Stereo Reconciliation Record – Annexure-III

Distribution

Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production & Quality Control

History

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Annexure -I

Sr. No._________ Date: ______________

To,

______________________

Product Name:- _______________________________ B. No.:_____________________

Type of Stereo for Foil: – Flat / Grooved
Stereo Size:-
Qty. Required:-
Type of Stereo for carton / Others (Specify)………………….: – Flat
Stereo Size:-
Qty. Required:-

Stereo Detail for Foil:-

Stereo Detail for Carton / Others (Specify)………………………:–

Prepared By

(Printing In-charge)

Checked By

(Production)

Verified By

(QA)

Annexure-II

Date
Product Name		B. No.
Batch Size		Mfg. Date
Exp. Date		M.R.P.

Impression of Stereos:

Done By

(Operator)

Checked By

(Printing In-Charge)

Counter Checked By

(Production)

Verified By

(QA)

Annexure-III

No.

Product

B. No.

Stereo for

Qty. of Stereo Indented

Qty. of stereo

Received

Impression Cheeked

(Yes/No)

Rejected

(If any)

Total Good Stereos received

by/ On

Qty. Issued

Issued

By/On

Stereo received

By Prod./On

Balance Qty.

Verified

By QA/On

Re-issued

By QA/On

Balance Qty.

after re-issuance

Qty. returned

Returned By/On

Received By/On

Verified

By QA/On

Destroyed Qty.

Destruction

Done By

Destruction

Checked By

(Prod.) / On

Destruction

verified By

(QA) / On

Foil

Inner Carton

Outer Carton

Label

Other:

Foil

Inner Carton

Outer Carton

Label

Other:

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SOPs

Factory Acceptance Test for Blister Pack Machine

March 29, 2022February 6, 2023 ABHA

Factory Acceptance Test for Blister Pack Machine

machine name	:	BLISTER PACK MACHINE.
Client Name & address	:	M/S BLISCARE MACHINES, MUMBAI.
document name	:	factory acceptance test
PROTOCOL no.	:
Revision no.	:
MACHINE SR. NO.	:

Table of Contents

1.… SYSTEM DESCRIPTION & SALIENT FEATURES :…………………………………………………………….

2.… SYSTEM CHECKS :……………………………………………………………………………………………………………

2.1 Physical Check :……………………………………………………………………………………………………………..

TECHNICAL SPECIFICATIONS:……………………………………………………………………………………….
TECHNICAL SPECIFICATIONS OF SUBCOMPONENTS/BOUGHTOUTS :……………………………
MATERIAL OF CONSTRUCTION:………………………………………………………………………………………..
FALCON & CLIENT REMARK:………………………………………………………………………………………

SYSTEM DESCRIPTION :

Sr. No.	Description
The basic WEP3600 consists of the following subassemblies:
I	Structure Assembly The structure is enclosed on three sides are closed by frame and only back side covered with removable doors. Removing the knob side to access the machine back side assembly and Control Panels. The filter regulator for Main air inlet, dial Pressure Pneumatic solenoid valve assembly and Induction Motor with Worm reducer Gear Box Geared Motor for main drive assembly. Pack transport conveyor assembly..
II	Forming Station Assembly This consists of the main shaft with water jacketed housing and Vacuum, Vacuum ring assembly, Blister forming roller mounting main shaft with locking long Blot. Adjusting with forming roller assembly the Contact heater assembly will be there for Uniformly producing heat and transferred the same amount of heat to the forming foil to get Form the cavity uniformly.
III	Feeding Station Assembly This assembly consists of Variable vibration controlled Linear Vibrator assembly with Product Hopper and Universal Feeding Box with Feeding channel mounting holder. Below the Feeding Channel mounting assembly the dust collection point.
IV	Guide Track Assembly The Guide track assembly has 3 pieces of Guide Track length of 405mm with Impression plate assembly before sealing station
V	Sealing Station Assembly The sealing station assembly with the Counter sealing roller mounting shaft with cylindrical lock nut and pressure sealing roller mounted shaft. The drive side of Sealing station has a pneumatic cylinder for control the sealing pressure with flow control knob.
VI	Linear Indexing Station Assembly This consists of Linear Pusher assembly with eccentric stroke adjustable assembly with tie rod. The pusher assembly mounted on Linear indexing platform. Suitable size pusher use to fit in the assembly.
VII	Punch Station Assembly This assembly consists of Punch Tool mounting assembly bracket and four mounting pillar for tool mounting Punch Tool Assembly. The Punch tool assembly has punch guide plate so called as stripper plate, which guide the sealed web to punch and die plate. After punched the Blister strip the excess Trim will get cut by trim cutter blade mounted in punch tool assembly.
VIII	Pack Transport Conveyor Assembly The Pack track Conveyor assembly consists of endless conveyor belt with beck support conveyor. The conveyor basic drive connected with main machine drive to get a synchronize speed of conveyor for maintain the conveyor speed.

SYSTEM CHECKS :

2.1 Physical Check :

Method	Description	Acceptance Criteria	Observation	Sign/date
Outer Surface finish verification	Check Outer surface of machine	-Matt finish -Curved corner -No dent -No visible spot of welding
AC/DC panel checking	Visual check	-Should be available -Proper wiring
Document verification	Verification of calibration certificate of Digital Pressure Indicator, Pressure Gauge.	-Calibration certificated should be available
Document verification	Verification of MOC certificate	-MOC certificated should be available

Verified by:_____________________ Performed by: _____________________

TECHNICAL SPECIFICATIONS

Maximum Base Foil Width	320mm – PVC/ PVC COATED PVDC Thickness Up to 350 Micron
Maximum Lidding Foil Width	320mm, All Heat Sealable Aluminum Foils with 9gsm HSL.
Minimum – Maximum Punch Index	30 – 110mm (Optional 136mm)
Minimum – Maximum Form Depth	3mm to 16mm
Speed	Up to 120 Punching Cycle
Product Feeding	Automatic – By Universal Feeder

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TECHNICAL SPECIFICATIONS OF COMPONENTS/BOUGHT OUTS

Sr No	Description	Speciation
1. Main Structure
Material		Stainless steel, SS 304
Surface Finish		Mate Finished Pre Buffed Sheets
2. Main Frame/ Forming/ Sealing and Punching Station with Form Heaters Assembly
Position.		Above main structure
Manufacturer		Bliscare Machines
Specification		Forming/ Sealing and Punching Station
Material		Aluminum HE 30 Grade
Surface Finish		Ground Finish with Anodizing
3. Drive Assembly of Form/ Seal and Punch Assembly
Manufacture Bliscare Machines		Position in the Station Drive Zone
Made of		MS Harden Mild Steels with 60 HRC
Finish		Blacking
4. Indexing Station Drive Assembly
Position.		Between Sealing and Punching Station
Manufacturer		Mechanical Linear Indexing
Specification		Linear Type
Material		Timer Belt Continental
Surface Finish		Anodizing and ENP coating.
5. Station Drive Assembly
Position.		Below Station assembly
Manufacturer		Bliscare Machines
Surface Finish		Wire Cutting & ENP Coating

MATERIAL OF CONSTRUCTION
All Product Contact Parts are made by SS 304 and Aluminum HE 30 Grade
All SS 304 / Aluminum HE 30 Grade materials from India’s reputed Suppliers

FALCON & SANO CITO REMARK:

Falcon Remark :

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

___________________________(Sign/date)

Sano Cito Remark :

Sr. No.	SANO CITO		FALCON
Sr. No.	Name	Sign & Date	Name	Sign & Date
1
2
3

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Qualifications & Validations

PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM

March 24, 2022February 6, 2023 ABHA

PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM

OBJECTIVE

To describe the Performance Qualification procedure to be used during validation of purified water system in order to:

a) ensure the system reproducibility over an appropriate time period as per user requirement specifications.

b) ensure that the system is showing consistency in producing water of pre-established specifications.

SCOPE

This procedure applies to the Performance Qualification or Validation of Purified Water System.

RESPONSIBILITY

Validation team shall be responsible for the preparation and checking of the Performance Qualification/ Validation protocol.

Plant Head, Head-Quality Control & Head-Quality Assurance shall be responsible for the approval of Performance Qualification/ Validation protocol.

Head -Quality Control shall be responsible for facilitating analysis of water samples, evaluations of the test results and compilation of validation data.

Head -Quality Assurance shall be responsible for approval of the Performance Qualification / Validation Report and certification after successful validation of purified water system

ABBREVIATIONS AND DEFINITIONS

PQ: Performance Qualification; documented verification that the integrated system or subsystem functions as intended, in its normal operating environment.

DQ: Design Qualification.

IQ: Installation Qualification.

OQ: Operational Qualification

Validation Team: Trained representatives from Quality Assurance, Quality Control,Engineering and Production departments participating in validation. For water system validation, the validation team members shall enlist their names & signatures as per Annexure-8

HVAC: Heating, Ventilation and Air-Conditioning

USP: United States Pharmacopoeia

BP: British Pharmacopoeia

IP: Indian Pharmacopoeia

Ph.Eur.: European Pharmacopoeia

UV: Ultra Violet

TOC: Total Organic Carbon

EDI: Electrodeionization

SS: Stainless Steal

SDI: Silt Density Index

HDPE: High Density Polyethylene

BRIEF DESCRIPTION OF WATER SYSTEM

Raw Water sourced from Bore well is converted into purified water complying with current USP/ BP/ IP/ Ph.Eur. This water is chlorinated by Sodium Hypochlorite Solution (NaOCl) so as to maintain residual free chlorine. Dosing is done using electronic metering pump. Chlorinated water is stored in an under ground tank and from the tank it is pumped to pass through a Multi Grade Filter (MGF) for removal of suspended solids. Sodium meta-bisulphite (SMBS) dosing system is provided on the outlet discharge pipe of MGF to remove the residual chlorine. Water after de-chlorination is stored in 10 Kiloliter HDPE storage tank. Water from this tank is pumped to distribute in two loops:

Feed to soft water plant
Treated water distribution

Filtered water then is passed through softener to reduce Hardness. Softened water is further treated to generate high purity water as per current USP/ BP/ IP/ Ph. Eur. standards for purified water.

Soft water from the softener is stored in a HDPE storage tank of capacity 10 KL. Soft water from this tank is supplied to different utilities such as Boilers, Cooling towers; Chillers and hot water make up tank of HVAC and Purified water generation plant. Soft water will be stored in the feed water tank to the RO.

Soft water from softener may form scaling in Reverse Osmosis (RO) membranes, to avoid that special anti-scalant is added to the soft water. pH of the water is maintained at 7.5-8.5 at the inlet of the Reverse Osmosis unit through pH correction dosing system

Soft water is further passed through single stage SDI filtration (with filter of 5µ) before pumping into Purified Water Generation System (consisting of RO and EDI units). For protecting the RO membrane incase of accidental entry of free chlorine water ORP meter is installed in the RO feed water. As soon as ORP meter senses the free chlorine it will trip the system and open the flow divert valve to avoid damage to RO membrane.

Purified water is stored in an SS Storage Tank Assembly and is distributed through loop system to various sections. Before final distribution the purified water is passed through UF/UV purifiers.

PRE-REQUISITES

Before validating the Water system following should be ensured:

Successful completion of Operational Qualification of Water System as per Protocol

Availability of Test Protocols for testing of water produced at different stages

Availability of following Draft SOP(s)

Operation and Regeneration of MGF & soft water plant, etc

Operation of the purified water system

Sanitization (purified water generation system & Distribution system)

Water Sampling (also describing sampling micro testing)

Availability of all the relevant Log books of water system

QUALIFICATION/ VALIDATION PROCEDURE

Qualification/ Validation Strategy

This Validation Study shall be executed in three phases:

Phase- 1
Phase – 2
Phase – 3

Phase- 1

Phase-1 shall last for minimum two (2) weeks or unless water of every stage meets the specifications during which preliminary sampling of water shall be done to assure that the system is ready to go into Phase- 2, the prospective phase of validation. (refer sampling and testing plan for Phase-1 & Phase-2)

During this phase operating, regeneration and sanitization procedures shall be verified & frequencies for sanitization shall be established and fixed.

On completion of Phase-1, report (Annexure-7) shall be prepared and it shall be checked and approved for further proceeding to Phase-2.

In case there is any deviation in Phase-1, corrective action shall be taken and after corrective action (recording shall be done as per Annexure-4), validation activity shall be continued. On the basis of Phase-1 data Alert and Action levels for key quality attributes like TOC, Conductivity and Microbial Count shall be established. Criteria for taking alert limit and action limit shall be as follows:

Alert limit = Average Value + 2σ

Action limit = Average Value + 3σ

After Phase-1, sampling shall be continued till the approval of Phase-1 report as per Phase-1 schedule and their respective data shall be incorporated in the Phase-2 report.

Phase-2

Phase-2 shall last for Four (4) weeks with sampling frequency similar to Phase-1. (refer sampling and testing plan for Phase-1 & Phase-2)

This phase shall demonstrate the system consistency with respect to desired water quality when operated after sanitization in conformance with SOP(s). During this phase Alert and Action levels for key quality attributes like TOC, Conductivity and Microbial Count shall be verified.

In case there is any deviation in Phase-2, corrective action shall be taken and after correction action (recording shall be done as per Annexure-4)

Purified water system shall be cleared for the production after successful completion of Phase-2

A report (Annexure-7) shall be prepared after completion of Phase-2 study

Phase-3

Phase-3 shall last for about eleven (11) months with each sampling point being covered every week (refer sampling and testing plan for Phase-3)

In this concurrent phase of validation routine monitoring shall be conducted and seasonal variation shall be studied.

Scheduled preventive maintenance shall be finalized at this phase of water system validation.

A schedule for periodic review of the system performance and re-qualification or revalidation shall also be instituted after the completion of this phase.

A report (Annexure-7) shall be prepared after completion of Phase-3 study. Trending of data shall be done.

Water system shall be evaluated at following stages through various sampling points and user points:

Raw water (Stage-1)
Raw Water after Chlorination (Stage-2)
Dechlorinated Water after MGF treatment (Stage-3)
Soft Water after Softener (Stage-4)
Soft Water after 5 micron filter [Feed water to Purified Water Generation System consisting of Reverse Osmosis (RO) and Electrodeionization (EDI) units] (Stage-5)
Water after RO treatment (Stage-6 & 7)
Water after EDI treatment (Stage-8)
Water after Ultra filtration (Stage-9)
Purified Water from Purified Water Storage Tank (Stage-10)
Purified water Return from Distribution loop/UV lamp (Stage-11)
Purified water from all user points (Stage-11)

Description of Sampling Points

The following sampling points shall be defined for validation and monitoring the purified water system and its distribution during validation through three phases

S.No	Sampling Point Description	Code
1	Raw Water (Bore well)	S-1
2	MGF-001 Inlet (Multi grade filter)	S-2
3	Dechlorinated Water Storage Tank	S-3
4	ISFD-001 Outlet (Softener)	S-4
5	MCF-001 Outlet (5Micron Filter)	S-5
6	RO-001 Outlet (Reverse Osmosis)	S-6
7	RO-002 Outlet (Reverse Osmosis)	S-7
8	EDI-001 Outlet (Electro De-Ionizer)	S-8
9	UF-001 Outlet (Ultra filter)	S-9
10	T-2101 (Purified water storage tank)	S-10
11	UV-2101 outlet	S-11
12	Purified water return from distribution	S-12
13	Fabrication-1	S-13
14	Fabrication-2	S-14
15	Fabrication-3	S-15
16	Coating-1	S-16
17	Coating-2	S-17
18	Coating-3	S-18
19	Product development lab (PDL)	S-19
20	Bin wash area	S-20
21	Bin wash machine	S-21
22	Ointment wash	S-22
23	Ware house	S-23
24	Drain point-1	S-24
25	Drain point-2	S-25
26	Drain point-3	S-26

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List of Tests and Acceptance Criteria

Raw Water (Stage-1)

Chemical analysis (C1; refer Table-1) of Raw water

Table-1

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	6.0 to 8.5 at 25ºC
Total Hardness	NMT 1000 ppm
Total Dissolved Solids	NMT 800 ppm
Total Suspended Solids	NMT 1000 ppm
Total Alkalinity	NMT 400 ppm
Chloride	NMT 250 ppm
Sulphates	NMT 500 ppm
Heavy Metals	NMT 0.5 ppm
Microbiological analysis (M1) of Raw water
Total Aerobic Microbial Count	Informative
Yeast and Moulds	Informative
Escherichia coli	Informative
Salmonella species	Informative
Pseudomonas aeruginosa	Informative
Staphylococcus aureus	Informative

After Chlorination (Stage-2)

Free chlorine content (FC1) of Raw water after chlorination should range from 0.5-1 ppm

Dechlorinated Water (after MGF treatment; Stage-3)

Chemical analysis (C2; refer Table-2) of dechlorinated water storage tank

Table-2

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
Taste	Agreeable
pH	6.0 to 8.5 at 25ºC
Total Hardness	NMT 800 ppm
Total Suspended Solids	NMT 500 ppm
Residual Free Chlorine	NMT 0.2 ppm (on-line measurement)
Microbiological analysis (M2) of dechlorinated water from dechlorinated water storage tank
Total aerobic microbial count	Not More Than 500 CFU/ml
Yeast and Mould	Not More Than 10 CFU/ ml
Escherichia coli	Should be absent
Salmonella species	Should be absent
Pseudomonas aeruginosa	Should be absent
Staphylococcus aureus	Should be absent

Soft Water (Stage-4)

Chemical analysis (C3; refer Table-3) of Softened water in the ISFD-001 (sampling point) Outlet (Softener)

Table-3

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	6.0 to 8.5 at 25ºC
Total Hardness (as CaCO₃)	NMT 10 ppm
Total Dissolved Solids	NMT 500 ppm

Soft Water after 5 µM filter (Stage-5)

Chemical analysis (C4; refer Table-4) of Softened water in the MCF -001 Outlet (5 micron filter)

Table-4

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	7.5 to 8.5 at 25ºC
Residual Free Chlorine	NMT 0.02 ppm (on line measurement)

RO Water (Stage-6)

Chemical analysis (C5; refer Table-5) of RO-001 Outlet water

Table-5

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	Informative
Total Dissolved Solids	Informative
Conductivity in µS.cm^-1 at 25ºC	Informative (on-line measurement)

RO Water (Stage-7)

Chemical analysis (C6; refer Table-6) of RO-002 Outlet water

Table-6

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	5.0 to 7.0 at 25ºC
Total Hardness	NMT 1 ppm
Total Dissolved Solids	Informative
Conductivity	NMT 30µS.cm^-1 at 25ºC (on-line measurement)
Sulfide	NMT 0.01 ppm
Silica(SiO₂)	NMT 1 ppm

EDI Water (Stage-8)

Chemical analysis (C7; refer Table-7) of EDI-001 Outlet water

Table-7

Test

Acceptance Criteria

Conductivity

NMT 1.3 µS.cm^-1 at 25ºC

(on-line measurement)

Water after Ultra Filtration/ (Stage-9)

Chemical analysis (C8; refer Table-8) of Ultra filter(UF-001) Outlet water

Table-8

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	5.0-7.0 at 25ºC
Conductivity	NMT 1.3 µS.cm^-1 at 25ºC

Purified Water from Storage Tank outlet (Stage-10)

Chemical analysis (C9; refer Table-9) of Purified Water from Storage Tank outlet

Table-9

Test	Acceptance Criteria
Description	Clear, Colourless and Odourless liquid
pH	5.0-7.0 at 25ºC
Conductivity	NMT 1.3 µS.cm^-1 at 25ºC
Acidity or Alkalinity	a) Should not produce red colour with 10 ml of sample quantity using 0.5ml methyl red solution. b) Should not produce blue colour with 10 ml of sample quantity using 0.1ml bromothymol blue solution.
Ammonium	NMT 0.2 ppm
Calcium and Magnesium	To 100 ml add 2 ml of ammonium chloride buffer solution pH 10.0, 50 mg of mordant black 11 triturate and 0.5 ml of 0.01 M sodium edetate. A pure blue colour is produced.
Heave metals	NMT 0.1 ppm
Chloride	No change in the appearance of solution up to 15 min
Sulphate	No change in the appearance of solution up to 60 min
Nitrate	NMT 0.2ppm
Oxidisable substances	Pink colour should be retained, for 100 ml of sample + 10 ml of H₂SO₄ + 0.1 ml of 0.02 M KMnO₄
Carbon Dioxide	Should produce clear mixture
Residue on Evaporation	NMT 0.001% w/v
Microbiological analysis (M3)
Total Aerobic Bacterial Count	NMT 100 CFU /ml
Yeast and Moulds	NMT 1.0 CFU /ml
Escherichia coli	Should be absent
Salmonella species	Should be absent
Pseudomonas aeruginosa	Should be absent
Staphylococcus aureus	Should be absent

Purified Water Return from Distribution Loop (Stage-11)

Chemical analysis (C9) of Purified Water return from Distribution Loops, UV Lamp and User Points. Refer Table-9 for specifications and acceptance criteria.

Operational Checks during Validation

Following operating parameters for Purified water system shall be monitored every 1 hour during running condition and shall be summarized along with Phase-wise reports.

Table-10

Parameter	Acceptance Criteria
MGF-001 Inlet water pressure	Not less than 3.5 kg/cm²
ISFD-001 Inlet water pressure	Not less than 3.5 kg/cm²
RO-I Inlet water flow rate	Not less than 5.23 m³/h
RO-II .Inlet water flow rate	Not less than 3.66 m³/h
RO-I Operating pressure	Not more than 7.7 kg/cm²
RO-II Operating pressure	Not more than 6.8 kg/cm²
EDI Inlet water flow rate	Not less than 2.93m³/h
EDI Operating pressure	Not more than 3.0 kg/cm²
UF Inlet water flow rate	Not less than 2.64 m³/h
UF Inlet water pressure	2 to 3 kg/cm²
TOC( In the loop)	NMT 500ppb

This parametric recording shall be done in the format given as Annexure-9

Other operational parameters like UV light consumption, pressure differential for all the filters, etc shall also be monitored and recorded in respective log books during validation studies

Sampling Plan and Testing Plan

Sampling and testing plan for Phase-1 & Phase-2

Following table indicate the sampling and testing plan for Phase-1 & Phase-2.

Table-11

Sampling point Description	Sampling Point code	Stage	Week days
Sampling point Description	Sampling Point code	Stage	Sun	Mon	Tue	Wed	Thu	Fri	Sat
Raw Water (Bore well)	S-1	1	C1 M1	C1 M1	C1 M1	C1 M1	C1 M1	C1 M1	C1 M1
MGF-001 Inlet (Multi grade filter)	S-2	2	FC1	FC1	FC1	FC1	FC1	FC1	FC1
Dechlorinated Water Storage Tank	S-3	3	C2 M2	C2 M2	C2 M2	C2 M2	C2 M2	C2 M2	C2 M2
ISFD-001 Outlet (Softener)	S-4	4	C3	C3	C3	C3	C3	C3	C3
MCF-001 Outlet (5Micron Filter)	S-5	5	C4	C4	C4	C4	C4	C4	C4
RO-001 Outlet (Reverse Osmosis)	S-6	6	C5	C5	C5	C5	C5	C5	C5
RO-002 Outlet (Reverse Osmosis)	S-7	7	C6	C6	C6	C6	C6	C6	C6
EDI-001 Outlet (Electro De-Ionizer)	S-8	8	C7	C7	C7	C7	C7	C7	C7
UF-001 Outlet (Ultra filter)	S-9	9	C8	C8	C8	C8	C8	C8	C8
T-2101 (Purified water storage tank)	S-10	10	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
UV-2101 outlet	S-11	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Purified water return from distribution	S-12	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Fabrication-1	S-13	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Fabrication-2	S-14	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Fabrication-3	S-15	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Coating-1	S-16	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Coating-2	S-17	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Coating-3	S-18	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Product development lab (PDL)	S-19	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Bin wash area	S-20	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Bin wash machine	S-21	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Ointment wash	S-22	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Ware house	S-23	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Drain point-1	S-24	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Drain point-2	S-25	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Drain point-3	S-26	11	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3	C9 M3

Sampling and testing plan for Phase-3

Following table indicate the sample plan for Phase-3.

Table-12

Sampling point Description	Sampling Point code	Stage	Week days
Sampling point Description	Sampling Point code	Stage	Sun		Mon	Tue	Wed	Thu	Fri	Sat
Raw Water (Bore well)	S-1	1	C1 M1
ISFD-001 Outlet (Softener)	S-4	4	C3		C3	C3	C3	C3	C3	C3
T-2101 (Purified water storage tank)	S-10	10	C9 M3	C9 M3		C9 M3	C9 M3	C9 M3	C9 M3	C9 M3
Fabrication-1	S-13	11		C9 M3				C9 M3
Fabrication-2	S-14	11				C9 M3			C9 M3
Fabrication-3	S-15	11					C9 M3			C9 M3
Coating-1	S-16	11	C9 M3					C9 M3
Coating-2	S-17	11		C9 M3					C9 M3
Coating-3	S-18	11				C9 M3				C9 M3
Product development lab (PDL)	S-19	11	C9 M3				C9 M3
Bin wash area	S-20	11		C9 M3				C9 M3
Bin wash machine	S-21	11				C9 M3			C9 M3
Ointment wash	S-22	11					C9 M3			C9 M3

RECORDING/ DATA COMPILATION

During validation study the Data from each phase shall be compiled by Validation Team Representative from Quality Control in following formats

Tabulated Data- Date wise evaluations (Annexure-5)
Analytical Testing -Raw Data Sheet (Annexure-6)

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Uncategorized

Operation of Euroclean WD Wet & Dry Vacuum Cleaner

March 23, 2022February 6, 2023 ABHA

Operation of Euroclean WD Wet & Dry Vacuum Cleaner

Objective

To lay down a procedure for the operation of Euroclean WD Wet & Dry Vacuum Cleaner.

Scope

This SOP is applicable for the operation of Euroclean WD wet & dry vacuum cleaner used for cleaning purposes in the formulation plant.

Responsibility

Production Operator/Technician shall be responsible to follow the procedure mentioned in the SOP.
Production and IPQA personnel shall be responsible for the proper implementation of the SOP.

Accountability

Head of Production department & QA shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP: Standard Operating Procedure
WD: Model no. of vacuum cleaner
QA: Quality Assurance

Procedure

Assembling for Dry Vacuum Cleaner
Check the ‘Cleaned’ label and ensure the cleanliness of the area & equipment.
Unlock the clamps of the Euroclean WD.
Lift the motor assembly and fit the special fine dust filter and special dust filter firmly in place.
Fit the unit back in place and lock the clamps.

Operation for Dry Vacuum Cleaner

Connecting The Hose

Press the lever on the hose and push the hose into the suction end/blower end (depending on usage) of Euroclean WD Vacuum Cleaner.
Ensure that the hose shall be securely locked to the vacuum cleaner body. This shall enable to pull the unit gently, by holding the home while cleaning.

Connecting it to the power supply

The cable shall be pulled out from the cord winder outlet of the unit and plug it into the main socket unit.
After the use of Euroclean WD, the plug shall be removed from the main socket.
Then the cord winder switch shall be pressed which automatically winds back the power cord into the unit.

Switching it on the Euroclean WD

The power switch shall be pressed on either high or low position depending on the cleaning area and nature of dust.
The motor shall start and the pop-up indication shall rise up from the exhaust or blower port.

Assembling for wet vacuum cleaner

Unlock the clamps of the Euroclean WD.
The special dust filter and special fine dust filter shall remove.
Fit the rubber gasket, the motor assembly shall be put back into the unit and lock the clamps.

Operation for wet vacuum cleaner

Connecting the hose

Press the lever on the hose and push the hose into the suction end/blower end (depending on usage) of Euroclean WD Vacuum Cleaner.
Ensure that the hose shall be securely locked to the vacuum cleaner body. This shall enable to pull the unit gently, by holding the home while cleaning.

Connecting it to the power supply

The cable shall be pulled out from the cord winder outlet of the unit and plug it into the main socket unit.
After the use of Euroclean WD, the plug shall be removed from the main socket.
Then the cord winder switch shall be pressed which automatically winds back the power cord into the unit.

Switching it on the Euroclean WD

The power switch shall be pressed on either high or low position depending on the cleaning area and nature of dust.
The motor shall start and the pop-up indication shall rise up from the exhaust or blower port.

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy – Quality Assurance
Controlled copies – Quality Assurance & Production

History

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SOPs

Entry & Exit in Microbiology Laboratory

March 22, 2022February 6, 2023 ABHA

Entry & Exit in Microbiology Laboratory

Objective

To lay down a procedure for entry & exit in Microbiology Laboratory.

Scope

This SOP is applicable for entry & exit in the microbiology laboratory

Responsibility

A microbiologist is responsible to follow this SOP.

Accountability

Department Head & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP: Standard Operating Procedure
QC: Quality Control

Procedure

Entry Procedure

Enter into the airlock – I by pushing the door and then remove apron, caps, slippers, etc. and keep it in lockers.
Disinfect the hands with disinfectant solution 70% Iso Propyl Alcohol.
Wear a pair of sterile gloves.
Take the sterile gown pack from the garment cubicle.
Take the sterile headgear from the pack and wear the headgear first. Ensure that hairs are completely covered.
Take the sterile gown from the pack and wear it. Ensure that the neck of the head cover is folded inside the gown.
Wear the booties & wipe the hands with disinfectant solution.
Enter into the airlock – III and then in the sterility testing area by opening the door with the help of the elbow.

Exit Procedure

Enter into the airlock – III by pulling the door.
Then enter into the airlock – II and take out the gown, headgear, gloves, and booties put them on the used garments labeled bin.
Take the aprons from the cabinet and wear them. Wear the slippers and wipe the hands with disinfectant and enter the laboratory.

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy – Quality Assurance
Controlled copies – Quality Control

History

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Uncategorized

Internal Audit and Self Inspection

March 22, 2022February 6, 2023 ABHA

Internal Audit and Self Inspection

Objective

To lay down a procedure for periodic internal audit and self-inspection to ensure current Good Manufacturing practices compliance.

Scope

This Standard Operating Procedure is applicable to all departments of the formulation plant of pharma industries.

Responsibility

Audit Team: Auditing the facility and preparing audit report comprising of recommendations and corrective action necessary for respective
Auditee Head: Head of the audited department, to ensure access is provided to the internal audit team to the department and relevant documents required by the internal audit team. He or she shall also ensure that corrective actions are taken within a specified time frame as mentioned in the internal audit report.
Head-QA: Audit team constitution, audit schedule approval, and distribution of Audit Report and Head-QA shall also ensure the compliance to the

Accountability

Department Heads & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
Internal Audit: An onsite verification of activity used to determine the effective implementation of documented quality systems.
Self-Inspection: Verification of departmental activity used to determine the effective implementation of documented quality systems.
Audit: Word represents both Internal Audit and Self Inspection.
Auditor: A person who has the technical qualification or is trained or the experience to perform audits.
Auditee: A department to be audited.
QA: Quality Assurance
cGMP: Current Good Manufacturing Practices
Ltd.: Limited

Procedure

The audit shall be carried out at two levels. Self-inspection and Internal Audit.
Self-Inspection is done at the departmental level i.e. representative of the department shall perform an inspection of all the documents and activities done by the department. Self-Inspection shall be conducted once every two months. The Self Inspection shall have ±7 day’s acceptable tolerance and inspection shall be done within this period. These representatives shall be nominated as auditors by the Department Head and shall have direct reporting to the department head. An audit report shall be prepared and corrective and preventive action shall be determined, filed, and implemented. The representatives shall perform the audit of the previous month’s documents and activities.
Internal Audit shall be carried out by QA & / or by an audit team constituted by head QA in all operational departments. While selecting a team member for the audit team, the head QA shall ensure that the member is not from the same department for which the audit is to be carried out.
Internal Audit shall be carried out as per the schedule prepared by the QA department (For frequencies of Internal Audit refer to Annexure-IV). The month and department to be audited shall be mentioned in the internal audit planner (Annexure-III), which shall be prepared annually. This Internal audit planner shall be circulated to the concerned department by Head-QA, preferably in the month of April of every fiscal year. The actual dates of the audit shall be proposed by QA before executing the audit.
Quality Assurance shall mark the upper half box in red color for the planned date and the auditee department shall mark the lower half box in green color against the planned date as per their suitability.
The internal audit planner shall be distributed in triplicates, one copy each for a planned date from QA and the agreed date from the user department, and one for QA
department for execution reference.
The Internal audit shall have ±15 days acceptable tolerance and Audit shall be done
within this period.
If an internal audit of any particular department/activity is required towards the investigation/ addressing of the product complaint or product recall the same shall be performed at any time.
Internal audits may also be conducted before the inspection of any regulatory body.
During the audit, auditors shall use the checklists for each department as given in Annexure-I (a) to Annexure-I (i), but the scope of audit may not be restricted to the checklist only. In the checklist under the ‘Remarks’ column, the auditor shall mention whether the observation is adequate or inadequate.
The audit team shall evaluate the systems, processes, and functions of the department to ascertain the current level of the cGMP. The audit team shall check for compliance for the various procedures, raw data and record the findings in the “Internal Audit/Self Inspection Report” (Annexure-II).
The Auditor shall assign a seven-character number as ‘AAXX/YY’ in consultation with QA to Audit report where;
AA: Denotes the type of Audit i.e.
For Internal Audit ‘AA’ shall be represented as (IA)
For Self Inspection ‘AA’ shall be represented as (SI)
XX: Denotes respective serial number of Audit.
YY: Denotes respective year of the Audit.
e.g. Second Internal Audit of the year 2015 shall be numbered as IA02/15 and the third self-inspection audit in the month of March in the year 2015 shall be represented as SI03/15.
A new series of Audit report No. shall commence at the beginning of every fiscal year.
Observation made during the audit shall be discussed with the concerned in charge of the
concerned department and/or the head of the department. Depending on the nature of the findings and the risk associated with any non-compliance, the following classifications shall be used:
Critical: – Deficiencies that have a high probability of causing adverse consequences to the patient or consumer or may result in significant deviations in the safety, identity, strength, or purity of the product; or are a combination of major deficiencies which indicates a critical system failure.
Major: – Deficiencies that could potentially cause adverse consequences to the patient or consumer if left unaddressed could be considered indicative of poor control or are a combination of minor deficiencies which indicate a major system failure.
Minor: – A deficiencies which cannot be classified as critical or major.
Note: – A deficiency that is not related to GMP or regulatory conformance requirement (e.g. EHS), but warrants attention by the auditee.
Good Practice: – Demonstration of exemplary achievement of compliance or setting a precedent within the current industry standard.
Upon completion of the audit, the audit team shall compile the audit report comprising of recommendations, which shall be forwarded to the respective department head for corrective action and a tentative date for compliance. For Internal audit, the report shall be sent through Head-QA.
A register shall be maintained for self-inspection and Internal audit by QA regarding the issuance of the audit report to the concerned department Head (refer to Annexure-V)
For Internal audit reports, the concerned department head shall mention a corrective action plan and a tentative date for compliance based upon audit observations and shall send back the Audit Report within 15 working days of receipt of the Internal Audit report to QA.
Upon receiving back the internal audit report, Head-QA or his /her designee shall review the internal-audit report and shall verify the corrective action taken. If required, a follow-up audit shall be carried out by any member of the audit team. The review status of corrective action taken shall be mentioned in the respective column of the Internal Audit Report. A copy of the report compiled by the audit team shall be forwarded to the concerned department for final action and compliance.

If required, Head- QA shall discuss the action plans with the respective department head.
If Internal Audit Report is not received by QA within the specified time limit of working days, a reminder(s) shall be sent to the concerned department. A copy of this reminder(s) shall be attached with Internal Audit Report.

Finally, Head-QA shall notify the Director of about the critical audit findings & corrective action proposed/taken by the Auditee.
Results of previous internal audits shall be reviewed again during the next Internal Audit where no corrective action was taken.
Audit Planning and audit execution process are delineated in the “Flow chart for Internal Audit” for guidance (Annexure-VI & Annexure-VII).

Note:-The contents of the audit reports generated following this SOP are confidential and revelations of the observations in the audit reports to external auditors shall be at the discretion of Head Quality Assurance.

Forms and Records

Internal Audit Checklist – Annexure-I(a) to Annexure-I(i)
Internal Audit/Self Inspection Report – Annexure-II
Internal Audit Planner – Annexure-III
Frequency of Internal Audits – Annexure-IV
Internal Audit/Self Inspection Register – Annexure-V
Flow Chart for Internal Audit – Annexure-VI
Flow Chart for Internal Audit – Annexure-VII

Distribution

Master Copy: Quality Assurance
Controlled Copies: Administration, Production, Quality Assurance, Quality Control, Human Resource and Store

History

Date	Revision Number	Reason for Revision
	I	Periodic revision
	II	Periodic revision
	III	Editorial changes & Periodic revision
	IV	Periodic revision & elaboration of procedure
	V	Amendment of SOP Title, change in format as per the new format, modification in procedure and annexures

Internal Audit Planner

Department

Months

Apr.

May

June

July

Aug.

Sept.

Oct.

Nov.

Dec.

Jan.

Feb.

Mar.

Production

Quality Control

Engineering

Quality Assurance

RM Store

PM Store

FG Store

Administration & Housekeeping

HRD

The actual dates of the audit shall be confirmed before the audit schedule.

Prepared by: Approve by:

Self-Inspection Planner

Department	Months
Department
Production
Quality Control
Engineering
Quality Assurance
RM Store
PM Store
FG Store
Administration & Housekeeping
HRD

The actual dates of the audit shall be confirmed before the audit schedule.

Prepared by: Approved by:

Internal Audit/ Self Inspection Checklist

Audited Department: Auditor: Audit Date:
Inspection Check List for Raw Material Store
S. NO.	CHECKLIST	REMARKS
1	Are incoming material and components quarantined until approved for use?
2	Is there any material without the label?
3	Are all materials stored off the floor?
4	Are all the raw materials stored on pallets?
5	Are materials spaced to allow for cleaning and labeling?
6	Is there any material without a label showing correct status (i.e. quarantined/approved / rejected)
7	Is there a clear demarcation for the following areas : a) Quarantine b) Approved c) Rejected
8	Observe the staging area:
	i. Is the access to the area restricted to authorized personnel?
	ii. Is there proper segregation of material issued for different batches?
	iii. Is there a document indicating material movement in the staging area?
9	Is there an inventory movement record?
10	Is there a stock rotation program if yes, is it followed. Crosscheck five random readings?
11	Whether FIFO & FEFO system is followed?
12	Is the area segregated for raw and packing material?
13	Is the area adequate for physical separation between different materials to prevent mix-ups?
14	Are the material containers visually inspected, cleaned, and weighed at the time of receipt? Check the receipt log.
15	Is material stored as per their status: quarantine, Hold, approved/released or rejected.
16	Are material requiring special storage conditions stored as per requirement?

S. NO.	CHECKLIST	REMARKS
17	Are the labels with complete information duly signed, written clear and legible text?
18	Is sampling done as per the sampling plan by QC?
19	Are the sampled containers labeled as ‘SAMPLED’?
20	Are the containers re-sealed after sampling under supervision?
21	Is sampling being documented in logbook?
22	Is dispensing being carried out in segregated environment?
23	Does the dispensing area have adequate exhaust and environmental monitoring (RH and temperature).Check records
24	Is Reverse LAF of Dispensing Booth working properly?
25	Is the dispensing area clean and clear of previous dispensing (check the equipment log, if any)
26	Check if the list of employees is available and updated.
27	Observe dispensing operation:
	i. Is it conducted by authorized person under supervision of production / IPQA?
	ii. All dispensed material properly packed in suitable container / double polybag and labeled?
	iii. All the calculations / weights checked by production / IPQA?
	iv. Are the original container re-sealed or closed after use?
	v. Observe the area after completion of dispensing?
	vi. Is there a documented procedure of cleaning of dispensing area after dispensing (i) between batches of same product (ii) between batches of different products?
28	Is the person dispensing raw material wearing gloves/masks/goggles?
29	Is the weighing balance serviced / calibrated :
	i. Platform balance
	ii. Electronic balance
30	Are the dispensing tools (Scoops, spatula, vessels, and cylinders) used after wash water analysis / QC certification for release?
31	Is the movement of man & material logical within stores and from stores to the production area?
32	Is the dispensed material moves under supervision from stores to production?
33	Is there a provision for dispensing of extra or additional material is it followed?

S. NO.	CHECKLIST	REMARKS
34	Are lighting and ventilation adequate to facilitate comfortable working?
35	Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
36	Check if the emergency exits in the building are maintained and unobstructed.
37	Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
38	Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?
39	Are the SOPs for the following maintained and updated: i. Dispensing of Raw Material and transfer of dispensed material from RM store to Production. ii. Handling of Obsolete / Rejected Raw Materials iii. Cleaning of Equipments in Raw Material Store iv. Cleaning of Raw Material Store Area
40	Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
41	Check if cleaning records are maintained.
42	What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
43	Are the personnel trained in personnel Hygiene? Is the training documented?
44	Is SOP and training of personnel Records available? Is the relevant information like study material, attendance record, evaluation record, re-training record etc available?
45	i. Is the list for storage condition of products available? ii. Are products stored as per the storage conditions?
46	Check if fire extinguishers are installed, properly labeled and preventive maintenance records maintained.
47	Are complete index and complete set of SOPs available?
48	Are the returned goods, recalled goods, expired goods completely demarcated?

S. NO.	CHECKLIST	REMARKS
49	Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
50	Is environmental condition records being maintained and recorded regularly?
51	Are sewage, trash, etc. disposal system adequate?
52	Are proper log maintained, available of all Rejected material in Rejected area room?
53	Are there any insects (Flies, mosquito’s, etc.) in the Receiving Bay?
54	Do the list of Storage Materials is Displayed on all Storage areas?
55	Do the Dispensing Booths are properly cleaned and Labeled?
56	Do Batch Staging Area have a yellow Line?
57	Do Calibration records are available for Weight Boxes?
58	Do all Weights are Shrink Wrapped?
59	Do all vacuum cleaners are properly cleaned and placed at respective places?
60	Are there any Dust found in Waste bins?
61	Are controlled substance kept under lock and key and purchase/consumption records maintained?
62	Are empty capsules stored under proper temperature & humidity and record Maintained?
63	Are cleaned and uncleaned weighing equipments stored separately?
64	Are hazardous substances stored separately?

Audited Department: Auditor: Audit Date:
Inspection Check List for Storage of Packing Materials
S. No.	CHECKLIST	REMARKS
1	Are incoming material and components quarantine until approved for use?
2	Are all materials stored off the floor?
3	Are materials spaced to allow for cleaning and labeling?
4	Are the packing materials of different products properly segregated?
5	Is the area adequate for physical separation between different materials to prevent mix-ups?
6	Is material stored as per their status: quarantine, approved / released or rejected?
7	Are the quarantine, approved / released or rejected area completely demarcated?
8	Whether each pack holding packing material appropriately labelled?
9	Are the printed labels kept under lock and key?
10	Is there a separate arrangement for printing of particulars as per coding record?
11	Are coded materials kept separately?
12	Are Operation and Cleaning records maintained separate for each printing machine?
13	Is there a stock rotation program if yes, is it followed. Crosscheck five random readings.
14	Is the FIFO & FEFO system being followed?
15	Are the SOPs for the following maintained & Updated: a) Cleaning of packing material stores area b) Handling of Obsolete (Rejected Printed/ Unprinted) packing material c) Issue of packing Materials and transfer of issued materials from packaging material store to production

S. No.	CHECKLIST	REMARKS
16	Observe the staging area: i. Is the access to area restricted authorized personnel? ii. Is there proper segregation of material issued for different batches? iii. Is there a document indicating material movement in the staging area?
17	Is there a separate area for work in progress goods, If yes i. Is the access restricted to authorized personnel? ii. Is the environment conditions monitored and recorded? iii. Are the product distinctly separated and stored? iv. Is there an inventory movement record?
18	Are the labels with complete information and duly signed by QC and written clear and legible text?
19	Is sampling done as per the sampling plan by QC?
20	Is dispensing being carried out in segregated environment?
21	Is there a provision for dispensing of extra or additional material is it followed
22	Check if the list of employees is available and updated.
23	Observer dispensing operation: i. Is it conducted by authorized person under supervision of production / IPQA? ii. All the calculations / weights checked by production / IPQA? iii. Are the original container re-sealed or closed after use? iv. Observe the area after completion of dispensing?
24	Is the movement of man & material movement logical within stores and from stores to the production area?
25	Is the dispensed material moves under supervision from stores to production?
26	Observe the printed packaging material area : i. Is the entry restricted to authorized people only? ii. Is stacking / storage of material adequate? iii. Are the materials of different product and pack size segregated properly? iv. Is the labeling adequate? v. Is there a stock rotation program? If yes, is it properly implemented vi. Is there a SOP for dispensing printed packaging material?
27	Is there a SOP for return of excess material e.g. online rejects etc from the production to stores

S. No.		CHECKLIST	REMARKS
	28	Are lighting and ventilation adequate to facilitate comfortable working?
	29	Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
	30	Check if the emergency exits in the building are maintained and unobstructed.
	31	Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
	32	Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?
	33	Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
	34	Check if cleaning records are maintained.
	35	What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
	36	Are the workforce trained in personnel Hygiene is the training documented?
	37	Is SOP and training of personnel available?
	38	Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
	39	Are a complete index and a complete set of SOPs available?
	40	Are the returned goods, recalled goods, expired goods completely demarcated?
	41	Are material requiring special storage conditions stored as per requirement?
	42	Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
	43	Is environmental condition records being maintained regularly and recorded?
	44	Are the weighing balances calibrated, Check records?
	45	Are sewage, trash, etc. disposal system adequate?

S. No.		CHECKLIST	REMARKS
	46	Are Proper log maintained & available of all Rejected material in Rejected area room?
	47	Are there any insects (Flies, mosquito’s, etc.) in the buffer zone?
	48	Do the change rooms are neat & maintained properly?
	49	Are All PVC/PVdC properly labeled and shrink wrapped?
	50	Do All foils are properly labeled and Shrink wrapped?
	51	Do Foil room is Locked or not?
	52	Do Batch Staging Area have a yellow Line?
	53	Do Calibration records are Available for Weight Boxes?
	54	Do all Weights are Shrink Wrapped?
	55	Do Label room is Locked or not?
	56	Is there Traceability for every label lock, label quantity in the label room?
	57	Are there any Dust found in Waste bins?

Audited Department: Auditor: Audit Date:
Inspection Check List for Storage of Finished Products
S. No.		CHECKLIST	REMARKS
1		Are the products stacked properly, product wise and Batch-wise?
2		Are materials spaced to allow for cleaning and labeling?
3		Are all the products placed on raised platforms?
4		Is sufficient space maintained between rows and at the back with the walls for efficient cleaning purpose?
5		Observe the staging area: i. Is the access to area restricted authorized personnel? ii. Is there proper segregation of material issued for different batches? iii. Is there a document indicating material movement in the staging area?
6		Is there a stock rotation program if yes, is it followed. Crosscheck five random readings.
7		Does the finished goods stock adequately maintained i.e. C-boxes closed, taped and status labeled?
8		Is the area adequate for physical separation between different materials to prevent mix-ups?
9		Is separate space for product recall / return allocated?
10		Are the material containers visually inspected, cleaned and weighed at the time of receipt check the receipt log?
11		Is proper sale record maintained?
12		Are material requiring special storage conditions stored as per requirement?
13		Is separate arrangement made for thermolabile products?
14		Is the movement of man & material movement logical within stores and from stores to the production area?
15		Is FIFO system being followed?
	16	Check if the list of employees is available and updated.

S. No.		CHECKLIST	REMARKS
	17	Are lighting and ventilation adequate to facilitate comfortable working?
	18	Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
	19	Check if the emergency exits in the building are maintained and unobstructed.
	20	Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
	21	Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
	22	Check if cleaning records are maintained.
	23	What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
	24	Are the workforce trained in personnel Hygiene is the training documented?
	25	Is SOP and training of personnel available is?
	26	Are batch distribution records available? i) Take 2 different batches and trace back their distribution.
	27	Is the current list of distributors available?
	28	Is the list for storage condition of products available? i) Are products stored as per the storage conditions?
	29	Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
	30	Are a complete index and a complete set of SOPs available?
	31	Are the returned goods, recalled goods, expired goods completely demarcated?
	32	Are material requiring special storage conditions stored as per requirement?
	33	Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
	34	Is environmental condition records being maintained regularly and recorded?

S. No.		CHECKLIST	REMARKS
	35	Are the weighing balances calibrated, Check records?
	36	Are sewage, trash, etc. disposal system adequate?
	37	Are Proper log maintained& available of all Rejected material in Rejected area room?
	38	Are there any insects (Flies, mosquito’s, etc.) in the buffer zone?
	39	Do the change rooms are neat & maintained properly?
	40	Do Batch Staging Area have a yellow Line?
	41	Do Calibration records are Available for Weight Boxes?
	42	Do all Weights are Shrink Wrapped?
	43	Are there any Dust found in Waste bins?

Audited Department : Auditor : Audit Date :
Inspection Check List for Documentation / Quality Assurance
S. No.	CHECKLIST	REMARKS
1	Are master copies of all the SOPs kept lock & Key?
2	Are process deviations recorded? i. Is the disposition of deviation being done by department head of QA? ii. Are corrective actions taken and recorded?
3	Does the current lists of all the SOPs available? i. Verify the master copies of SOPs. ii. Verify the SOP distribution and retrieval record. iii. Are superseded / obsolete SOPs marked accordingly and preserved separately. Choose any 3 current SOPs and / verify the status of their obsolete SOPs
4	Are the changes in the process, documents introduces as per controlled procedure? i. Is the record for change control maintained? ii. Is the disposition of change control done by department head of QA?
5	Is the current list of approved vendors available? i. Is the list of vendor’s segregated material wise? ii. Are the vendors approved by QA verified the records?
6	Is the list of RM / PM available & verify the code numbers?
7	Are market complaints processed and recorded by QA? i. Verify from the records and check the action taken on any 3 complaints.
8	Does a person of QA Deptt. remain present at the time of dispensing of RM?
9	Have all the trainings been carried out as per schedule and their assessment records maintained properly?
10	Are the self-inspections carried out as per schedule and records maintained?
11	Are all the Batch Manufacturing Records reviewed by the QA Manager before release of the product for sale?
12	Are the manufacturing and packing processes checked during production?
13	Are the BMRs of manufactured product kept properly in the record room year-wise?

S. No.	CHECKLIST	REMARKS
14	Are the records maintained for the approval of formats?
15	Is a consolidated list of all the documents and records maintained, department-wise?
16	Is the Quality Policy available and displayed?
17	Is the current Quality manual available?
18	Is the current SMF available & verify that all the information provided in SMF is updated?
19	Is the organogram of the company available? i. Does the organization chart demarcates the key responsibilities? ii. Are all the functional areas headed by key persons with adequate qualification, experience and training?
20	Is the list of current technical persons/key persons available for QC, Production, QA, Stores and Warehouse?
21	Are the copies of current manufacturing licenses available?
22	Is the list of all the products available? i. Verify the code numbers. ii. List of products for pharma market. iii. List of products for export market.
23	Does the current lists of specification / STPs for raw materials, finished products available? i. Verify the master copies of specification / STPs. ii. Verify specification / STP distribution and retrieval record. iii. Are superseded / obsolete specifications / STPs marked accordingly and preserved separately? Choose any 3 specification / STPs and verify the status of obsolete specifications / STPs.
24	Are Master formulae record available for all the products? i. Check the list of current MFRs. ii. Choose any 2 products and verify the Master formula records. iii. Are the master formula records authorized? iv. Does MFR includes expected final yields and intermediate yields?
25	Are batch manufacturing records (BMRs) issued and controlled as per the SOP? i. Choose any 4 products and verify the status of BMRs ii. Check the BMRs for any deviation or discrepancy.

Audited Department : Auditor : Audit Date :
Inspection Check List for Personnel
S. No.	CHECKLIST	REMARKS
1	Verify if the list of employees is current.
2	Is there a SOP for induction program of new recruits, Check records.
3	Verify if responsibilities of key personnel’s are clearly designated and documented.
4	Check induction and medical records of new joinee, select any 2 or 3 employees.
5	Check the availability of a qualified medical practitioner.
6	Mention the schedule for medical examination.
7	Choose 2-3 employees from each section/dept. verify the following: Health records, medical leave records
8	Verify whether a system exists for re-examination of an employee returning after a long medical leave by the company designated medical practitioner.
9	Is the training imparted for SOPs, GMP etc. i. Check staff training records. ii. Check external trainers record and verify the attendance through staff training records iii. Is the training literature and material preserved
10	Have employees’ undergone training on GMP, SOP and on job requirements, Are records available?
11	Verify training recording of three personnel.
12	SOP and training of personnel available. Is the relevant information like study material, attendance record, evaluation record, re-training record etc available.
13	Is the list of current technical persons available?
14	Is a list of personnel and the responsibilities available?
15	Is the first aid box provided at all the key locations?

Audited Department : Auditor : Audit Date :
Inspection Check List for Premises including personnel facilities & Sanitation / Housekeeping
S. No.	CHECKLIST	REMARKS
1.	Is the facility maintained in a clean and sanitary condition?
2.	Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
3.	Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?
4.	Verify, if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures?
5.	Does the facility have written procedures for the safe and correct use of cleaning sanitizing agent?
6.	Does the solution of cleaning and sanitation indicate rotation of Disinfectant If yes, check disinfectant inventory/ stock?
7.	Is the area outside the manufacturing area regularly got sprayed and record maintained?
8.	Are all the common Entry change Rooms cleaned as per daily schedule and record maintained?
9.	Are all the primary area change rooms cleaned properly and records maintained?
10.	Are all the secondary areas of all the sections cleaned regularly as per daily schedule and records maintained?
11.	Are all the lifts kept neat and cleaned?
12.	Are all the wash basins of all the change Rooms kept neat & clean?
13.	Is proper record maintained for the supply of factory uniforms to all the Employees?
14.	Check if cleaning records are maintained?
15.	Are the cleaning material kept at their proper places?

S. No.	CHECKLIST	REMARKS
16.	What is the level hygiene: Good (G)/Excellent (E)/Satisfactory (S)/Bad (B) (especially check nail, hair, etc.)
17.	Is each workers provided with two sets of uniforms/apparel Check records
18.	Are the gowning and degowning SOPs available and properly displayed in the change room?
19.	Is there a fixed schedule for washing of uniform? Check records.
20.	Are the workforce trained in personnel Hygiene is the training documented?
21.	Is the canteen or eating room facility neat and clean?
22.	Check if fire extinguishers are installed, checked, properly labeled and are fire safety drills performed as per schedule?
23.	Is written procedure describing safety measures is available?
24.	Are lighting and ventilation adequate to facilitate comfortable working?
25.	Check if the emergency exits in the building are maintained and unobstructed?
26.	Check if toilet cleaning and maintenance record are maintained, Availability of soap, hot and cold water air dryers, single service towels?
27.	Is waste being segregated as – plastics, organic, metal etc.?

Audited Department : Auditor : Audit Date :
Inspection Check List for Maintenance of buildings and Equipments / Engineering Services
S. No.	CHECKLIST	REMARKS
1.	Are written procedure established for maintenance of equipment and utilities?
2.	Are utilities maintain and monitored as per schedule?
3.	Is the preventive maintenance of major utilities being performed? a) Air Handling Units (AHUs) b) Compressed Air c) Vacuum Pump d) Air Conditioners e) Chiller Plant f) DG sets g) Boiler
4.	Does the filters in compressed air units are cleaned as per schedule? Check the SOP & records.
5.	Does the filters and prefilters in AHU system are cleaned as per schedule? Check the SOP & records.
6.	Is the cleaning procedure available for? a) Cooling towers b) Chiller plant c) Air handling units / duct / dampers d) Raw / DM Water storage tanks
7.	Are the service pipes clearly marked & indicate direction of flow (air, water, vacuum, LPG, Compressed Air)?
8.	Is there a schedule for the maintenance of service pipes? If yes, check the records.
9.	Is there a SOP on building maintenance? If yes, check the records?
10.	Does calibration planner is available and check for the compliance?
11.	Is the preventive Maintenance of all the Machine done according to their preventive maintenance schedule and records maintained?

S. No.	CHECKLIST	REMARKS
12.	Is the proper record regarding re-filling and monthly verification of conditions of Fire Extinguishers installed at various places maintained properly?
13.	Is the record of breakdown of machines maintained properly?
14.	Are the STP & ETP logbooks maintained?
15.	Are the Logbooks of all the DM Water tanks maintained?
16.	Are the Logbooks of all the Air Compressors maintained?
17.	Is the Logbook of the Electricity Meter Reading maintained?
18.	Are the Logbooks of Operation & service of Generators maintained?
19.	Is the Logbook of Operation & service of Boiler maintained?
20.	Is the Logbook of DM Water Plant Charging maintained?
21.	Is the list of critical spare parts for all the machines / equipment’s available? a) Check the list of critical spares for equipment; one each from production and utility. b) Check the stock ledger for the spare parts.
22.	Is the validation / calibration of equipment’s / guages performed as per schedule i) Check the validation / calibration records of minimum three equipment a)………………………………………….. b)………………………………………….. c)…………………………………………..
23.	Is the annual maintenance contract (AMC) / agreement available for the equipment which are not covered under preventive maintenance schedule?
24.	Check the record for job orders received and executed?

Audited Department : Auditor : Audit Date :
Inspection Check List for Equipment
S. No.	CHECKLIST	REMARKS
1.	Does all equipments used for manufacturing / processing are suitable in their size / capacity?
2.	Are the location of the equipment / machines in the facility acceptable?
3.	Is there adequate space for the following equipments? blender(s) dryer, compression machine(s) capsule fillers, bottle fillers etc.
4.	Are the equipment / machines properly design and installed?
5.	Are machine surfaces that direct contact the materials or finished goods non-reactive, non-absorptive and non-adaptive so as not to affect the product?
6.	Is the ideal equipment stored in a designated area?
7.	Is equipment cleaned promptly after used?
8.	Are written operating procedures available for each equipment used in manufacturing / processing or holding of components, in process material or finished product?
9.	Does the startup procedure ensure that equipment is thoroughly cleaned?
10.	Are all equipments have an identification no.?
11.	Do the major equipment have usage logs, cleaning logs, preventive maintenance logs?
12.	Are the relevant components of the machines calibrated and records maintained?
13.	Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
14.	Does the filters in the inlet of FBD are cleaned as per schedule? Check the SOP.

Audited Department : Auditor : Audit Date :
Inspection Check List for Production and In-process Control
S. No.	CHECKLIST	REMARKS
1.	Is the entry to the production area restricted?
2.	Are the work force trained in gowning / degowning / personnel hygiene / SOP / GMP etc? Check compliance to SOP
3.	Are production personnel attired as per SOP?
4.	Does complete set of SOPs available. Is it current?
5.	Verify the list of equipment and their identification codes.
6.	Is the BMR approved by QA prior to submission in doc cell?
7.	Check a current batch record from the shop floor.
8.	Are raw and packaging material tags attached in the BMR?
9.	Are the environmental conditions in different areas being monitored, maintained and recorded?
10.	In case of failure is the concerned department informed. Are the corrective actions documented?
11.	Is the impact of such environmental failure evaluated for impact on product?
12.	Is the procedure for line clearance followed? Question people regarding pack up at the end of shift or otherwise.
13.	Are the line clearance records being attached with the respective BMR?
14.	Does the machine indicate batch details and stage of processing of the batch?
15.	Are the in process checks being verified by IPQA personnel along with production personnel?
16.	Are the technical instruction being followed and entries being made in it, simultaneously?

S. No.	CHECKLIST	REMARKS
17.	Is there a procedure for issue, use and destruction of rubber stereos for coding during labeling and packing operations?
18.	Before the start of coding, are all specimens approved by IPQA?
19.	Are the approved specimen attached in the BMR of the product?
20.	How are coded unused material handled. Ask the manufacturing and packing supervisor?
21.	Are the labeling and packaging lines appropriate?
22.	Are there any physical separation between packaging lines?
23.	Is one product being processed in particular area?
24.	Is the wash water concept used for equipment?
25.	Are the washed and cleaned containers and machinery stored properly when not in use?
26.	Is the procedure for process deviation implemented? Check records.

Audited Department : Auditor : Audit Date :
Inspection Check List for Quality Control
S. No.	CHECKLIST	REMARKS
1.	Is the lab neat and orderly with enough space for working space?
2.	Lab Reagents: i. Reagents bottles properly labeled (Name, date of preparation, use before date, prepared by) ii. Reagents bottle properly closed iii. Placed as per temperature requirements
3.	Is there a ledger maintained for stock of chemicals and media?
4.	Is there proper storage area with different chemicals differentiation?
5.	Instrument Calibration / Maintenance i. Check out three instruments, check calibration SOP and records. ii. Is there a specific program schedule of calibration? iii. Where external standards are used verify their reliability? iv. All the instruments been calibrated in the operational range?
6.	Testing and Analysis i. Are all tests being performed as per Standard Test Procedure? ii. Are the testing report signed and dated by analyst? iii. Are the testing records counter checked by QC in-charge before release of sample? iv. Is there a SOP on out of specification results?
7.	Is entry to laboratory restricted?
8.	Are the standard bacterial cultures available?
9.	Is the areas passing record available?
10.	Is the SOP for cleaning validation available?
11.	Is gowning and degowning SOP available for Microbiological Lab?
12.	Is there a SOP for fumigation for Microbiological Lab?

S. No.	CHECKLIST	REMARKS
13.	Is there a SOP for cleaning and operation of LAF?
14.	Are the cleaning and operation checks implemented and recorded?
15.	Is there an SOP describing preparation, usage and discarding of used cultured media?
16.	Are the Solutions, Reagents, Indicators etc. stored in Orderly manner?
17.	Are the glass wares cleaned properly?
18.	Are the testing records maintained regularly giving all the required particulars?
19.	Is daily pH and conductivity of Purified water record maintained?
20.	Is chemical analysis of Purified water done daily and record maintained?
21.	Are all the instruments kept on shelves in orderly manner?
22.	Is the Humidity and Temperature record of stability chamber maintained regularly?
23.	Are all the Instruments in Micro Lab neat & clean?
24.	Is the Incubator in proper working order & required temperature maintained?
25.	Are Auto-claves having their SOPs near the Instruments?
26.	Are both Autoclaves validated and records maintained?
27.	Are log books of all Instruments in Micro lab maintained regularly?
28.	Are the Controlled Samples of all batches of all the products are preserved?
29.	Is Controlled samples register maintained?
30.	Is the Room temperature record of Control sample room maintained?

Audited Department : Auditor : Audit Date :
Inspection Check List for Ointments & Creams Section
S. No.	CHECKLIST	REMARKS
a)	MANUFACTURING
1.	Is there any material without label?
2.	Is every machine / equipment labelled with correct status?
3.	Are operators wearing: a) Factory uniform properly b) Gloves/Masks c) Foot wears
4.	Is the weighing balance serviced / calibrated and record maintained?
5.	Whether the Operation & Cleaning Log books for the following maintained & updated: a) Water Vessel b) Melting Tank c) Mixing Tank d) Storage Tank e) Planetary Mixer
6.	Is the batch preparation record compiled concurrently?
7.	Are there any Raw Material present in the department which belongs to two different products?
8.	Are the SOPs for the following maintained and updated: a) Cleaning of Mixing Tank during product changeover. b) Cleaning of Storage Tank
b)	TUBE FILLING
1.	Whether all the machines are labelled with correct status?
2.	Are the operators wearing full sleeve garments /gloves?
3.	Is there more than one product in the room?

S. No.	CHECKLIST	REMARKS
4.	Is the room clean and free of any evidence of other products?
5.	Are the following In-process controls being exercised by both Asstt. Mfg. Chemist & QA personnel: a) Weight variation b) Crimping & embossing check c) Cap tightening check
6.	Whether the Operation & Cleaning log-books for the following maintained & updated: a) Tube filling machine b) Transfer pump
7.	Is the filling record being compiled concurrently?
c)	TUBE PACKING
1.	Is there any material or container without proper label?
2.	Is the room clean and free of any evidence of other product?
3.	Whether all the details in packing record are being entered at appropriate timings?
d)	MISCELLANEOUS
1.	Is the line clearance procedure being followed?
2.	Are Cleaning log-books maintained separately for : a) Primary Area b) Secondary Area

Audited Department : Auditor : Audit Date :
Inspection Check List for Liquid Section
S. No.	CHECKLIST	REMARKS
a)	MANUFACTURING
	Is there any material without label?
	Is every machine / equipment labelled with correct status?
	Are operators wearing: a) Factory uniform properly b)Gloves/Masks c) Foot wears
	Whether the Operation & Cleaning log books for the following Maintained & Updated: a) Melting Tank b) Mixing Tank c) Storage Tank
	Is the batch preparation record compiled concurrently?
	Are there any Raw Materials present in the department which belong to two different products?
	Are the SOPs for the following maintained and updated: a) Cleaning of Mixing Tank during product changeover. b) b) Cleaning of Storage Tank
b)	BOTTLE FILLING
	Is there any packing / raw material or finished goods belonging to other products present in the department?
	Does the filling machine bear appropriate label?
	Has the filling machine been cleaned before commencement of filling?
	Is the fill volume checked?
c)	BOTTLE PACKING
	Is there any material or container without proper label?

S. No.	CHECKLIST	REMARKS
	Is the room clean and free of any evidence of other product?
	Whether all the details in packing record are being entered at appropriate timings?
d)	MISCELLANEOUS
1.	Is the line clearance procedure being followed?
2.	Are Cleaning log-books maintained separately for : a) Primary Area b) Secondary Area

Annexure-I (a)

Audited Department: Auditor: Audit Date:
Inspection Check List for Raw Material Store
S. NO.		CHECKLIST			REMARKS
1		Are incoming material and components quarantine until approved for use?
2		Is there any material without label?
3		Are all materials stored off the floor?
4		Are all the raw materials stored on pallets?
5		Are materials spaced to allow for cleaning and labeling?
6		Is there any material without a label showing correct status (i.e. quarantined / approved / rejected)
7		Is there a clear demarcation for the following areas : a) Quarantine b) Approved c) Rejected
8		Observe the staging area:
		i. Is the access to area restricted authorized personnel?
		ii. Is there proper segregation of material issued for different batches?
		iii. Is there a document indicating material movement in the staging area?
9		Is there an inventory movement record?
10		Is there a stock rotation program if yes, is it followed. Crosscheck five random readings?
11		Whether FIFO & FEFO system is followed?
12		Is the area segregated for raw and packing material?
13		Is the area adequate for physical separation between different materials to prevent mix-ups?
14		Are the material containers visually inspected, cleaned and weighed at the time of receipt? Check the receipt log.
15		Is material stored as per their status: quarantine, Hold, approved / released or rejected.
16		Are material requiring special storage conditions stored as per requirement?
S. NO.		CHECKLIST			REMARKS
17		Are the labels with complete information duly signed, written clear and legible text?
18		Is sampling done as per the sampling plan by QC?
19		Are the sampled containers labeled as ‘SAMPLED’?
20		Are the containers re-sealed after sampling under supervision?
21		Is sampling being documented in logbook?
22		Is dispensing being carried out in segregated environment?
23		Does the dispensing area have adequate exhaust and environmental monitoring (RH and temperature).Check records
24		Is Reverse LAF of Dispensing Booth working properly?
25		Is the dispensing area clean and clear of previous dispensing (check the equipment log, if any)
26		Check if the list of employees is available and updated.
27		Observe dispensing operation:
		i. Is it conducted by authorized person under supervision of production / IPQA?
		ii. All dispensed material properly packed in suitable container / double polybag and labeled?
		iii. All the calculations / weights checked by production / IPQA?
		iv. Are the original container re-sealed or closed after use?
		v. Observe the area after completion of dispensing?
		vi. Is there a documented procedure of cleaning of dispensing area after dispensing (i) between batches of same product (ii) between batches of different products?
28		Is the person dispensing raw material wearing gloves/masks/goggles?
29		Is the weighing balance serviced / calibrated :
		i. Platform balance
		ii. Electronic balance
30		Are the dispensing tools (Scoops, spatula, vessels, and cylinders) used after wash water analysis / QC certification for release?
31		Is the movement of man & material logical within stores and from stores to the production area?
32		Is the dispensed material moves under supervision from stores to production?
33		Is there a provision for dispensing of extra or additional material is it followed?
S. NO.		CHECKLIST			REMARKS
34		Are lighting and ventilation adequate to facilitate comfortable working?
35		Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
36		Check if the emergency exits in the building are maintained and unobstructed.
37		Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
38		Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?
39		Are the SOPs for the following maintained and updated: i. Dispensing of Raw Material and transfer of dispensed material from RM store to Production. ii. Handling of Obsolete / Rejected Raw Materials iii. Cleaning of Equipments in Raw Material Store iv. Cleaning of Raw Material Store Area
40		Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
41		Check if cleaning records are maintained.
42		What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
43		Are the personnel trained in personnel Hygiene? Is the training documented?
44		Is SOP and training of personnel Records available? Is the relevant information like study material, attendance record, evaluation record, re-training record etc available?
45		i. Is the list for storage condition of products available? ii. Are products stored as per the storage conditions?
46		Check if fire extinguishers are installed, properly labeled and preventive maintenance records maintained.
47		Are complete index and complete set of SOPs available?
48		Are the returned goods, recalled goods, expired goods completely demarcated?
S. NO.		CHECKLIST			REMARKS
49		Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
50		Is environmental condition records being maintained and recorded regularly?
51		Are sewage, trash, etc. disposal system adequate?
52		Are proper log maintained, available of all Rejected material in Rejected area room?
53		Are there any insects (Flies, mosquito’s, etc.) in the Receiving Bay?
54		Do the list of Storage Materials is Displayed on all Storage areas?
55		Do the Dispensing Booths are properly cleaned and Labeled?
56		Do Batch Staging Area have a yellow Line?
57		Do Calibration records are available for Weight Boxes?
58		Do all Weights are Shrink Wrapped?
59		Do all vacuum cleaners are properly cleaned and placed at respective places?
60		Are there any Dust found in Waste bins?
61		Are controlled substance kept under lock and key and purchase/consumption records maintained?
62		Are empty capsules stored under proper temperature & humidity and record Maintained?
63		Are cleaned and uncleaned weighing equipments stored separately?
64		Are hazardous substances stored separately?
Audited Department: Auditor: Audit Date:
Inspection Check List for Storage of Packing Materials
S. No.			CHECKLIST	REMARKS
1			Are incoming material and components quarantine until approved for use?
2			Are all materials stored off the floor?
3			Are materials spaced to allow for cleaning and labeling?
4			Are the packing materials of different products properly segregated?
5			Is the area adequate for physical separation between different materials to prevent mix-ups?
6			Is material stored as per their status: quarantine, approved / released or rejected?
7			Are the quarantine, approved / released or rejected area completely demarcated?
8			Whether each pack holding packing material appropriately labelled?
9			Are the printed labels kept under lock and key?
10			Is there a separate arrangement for printing of particulars as per coding record?
11			Are coded materials kept separately?
12			Are Operation and Cleaning records maintained separate for each printing machine?
13			Is there a stock rotation program if yes, is it followed. Crosscheck five random readings.
14			Is the FIFO & FEFO system being followed?
15			Are the SOPs for the following maintained & Updated: a) Cleaning of packing material stores area b) Handling of Obsolete (Rejected Printed/ Unprinted) packing material c) Issue of packing Materials and transfer of issued materials from packaging material store to production
S. No.			CHECKLIST	REMARKS
16			Observe the staging area: i. Is the access to area restricted authorized personnel? ii. Is there proper segregation of material issued for different batches? iii. Is there a document indicating material movement in the staging area?
17			Is there a separate area for work in progress goods, If yes i. Is the access restricted to authorized personnel? ii. Is the environment conditions monitored and recorded? iii. Are the product distinctly separated and stored? iv. Is there an inventory movement record?
18			Are the labels with complete information and duly signed by QC and written clear and legible text?
19			Is sampling done as per the sampling plan by QC?
20			Is dispensing being carried out in segregated environment?
21			Is there a provision for dispensing of extra or additional material is it followed
22			Check if the list of employees is available and updated.
23			Observer dispensing operation: i. Is it conducted by authorized person under supervision of production / IPQA? ii. All the calculations / weights checked by production / IPQA? iii. Are the original container re-sealed or closed after use? iv. Observe the area after completion of dispensing?
24			Is the movement of man & material movement logical within stores and from stores to the production area?
25			Is the dispensed material moves under supervision from stores to production?
26			Observe the printed packaging material area : i. Is the entry restricted to authorized people only? ii. Is stacking / storage of material adequate? iii. Are the materials of different product and pack size segregated properly? iv. Is the labeling adequate? v. Is there a stock rotation program? If yes, is it properly implemented vi. Is there a SOP for dispensing printed packaging material?
27			Is there a SOP for return of excess material e.g. online rejects etc from the production to stores
S. No.			CHECKLIST	REMARKS
	28		Are lighting and ventilation adequate to facilitate comfortable working?
	29		Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
	30		Check if the emergency exits in the building are maintained and unobstructed.
	31		Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
	32		Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?
	33		Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
	34		Check if cleaning records are maintained.
	35		What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
	36		Are the workforce trained in personnel Hygiene is the training documented?
	37		Is SOP and training of personnel available?
	38		Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
	39		Are a complete index and a complete set of SOPs available?
	40		Are the returned goods, recalled goods, expired goods completely demarcated?
	41		Are material requiring special storage conditions stored as per requirement?
	42		Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
	43		Is environmental condition records being maintained regularly and recorded?
	44		Are the weighing balances calibrated, Check records?
	45		Are sewage, trash, etc. disposal system adequate?
S. No.			CHECKLIST	REMARKS
	46		Are Proper log maintained & available of all Rejected material in Rejected area room?
	47		Are there any insects (Flies, mosquito’s, etc.) in the buffer zone?
	48		Do the change rooms are neat & maintained properly?
	49		Are All PVC/PVdC properly labeled and shrink wrapped?
	50		Do All foils are properly labeled and Shrink wrapped?
	51		Do Foil room is Locked or not?
	52		Do Batch Staging Area have a yellow Line?
	53		Do Calibration records are Available for Weight Boxes?
	54		Do all Weights are Shrink Wrapped?
	55		Do Label room is Locked or not?
	56		Is there Traceability for every label lock, label quantity in the label room?
	57		Are there any Dust found in Waste bins?

Audited Department: Auditor: Audit Date:
Inspection Check List for Storage of Finished Products
S. No.		CHECKLIST	REMARKS
1		Are the products stacked properly, product wise and Batch-wise?
2		Are materials spaced to allow for cleaning and labeling?
3		Are all the products placed on raised platforms?
4		Is sufficient space maintained between rows and at the back with the walls for efficient cleaning purpose?
5		Observe the staging area: i. Is the access to area restricted authorized personnel? ii. Is there proper segregation of material issued for different batches? iii. Is there a document indicating material movement in the staging area?
6		Is there a stock rotation program if yes, is it followed. Crosscheck five random readings.
7		Does the finished goods stock adequately maintained i.e. C-boxes closed, taped and status labeled?
8		Is the area adequate for physical separation between different materials to prevent mix-ups?
9		Is separate space for product recall / return allocated?
10		Are the material containers visually inspected, cleaned and weighed at the time of receipt check the receipt log?
11		Is proper sale record maintained?
12		Are material requiring special storage conditions stored as per requirement?
13		Is separate arrangement made for thermolabile products?
14		Is the movement of man & material movement logical within stores and from stores to the production area?
15		Is FIFO system being followed?
	16	Check if the list of employees is available and updated.
S. No.		CHECKLIST	REMARKS
	17	Are lighting and ventilation adequate to facilitate comfortable working?
	18	Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
	19	Check if the emergency exits in the building are maintained and unobstructed.
	20	Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
	21	Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
	22	Check if cleaning records are maintained.
	23	What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
	24	Are the workforce trained in personnel Hygiene is the training documented?
	25	Is SOP and training of personnel available is?
	26	Are batch distribution records available? i) Take 2 different batches and trace back their distribution.
	27	Is the current list of distributors available?
	28	Is the list for storage condition of products available? i) Are products stored as per the storage conditions?
	29	Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
	30	Are a complete index and a complete set of SOPs available?
	31	Are the returned goods, recalled goods, expired goods completely demarcated?
	32	Are material requiring special storage conditions stored as per requirement?
	33	Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
	34	Is environmental condition records being maintained regularly and recorded?
S. No.		CHECKLIST	REMARKS
	35	Are the weighing balances calibrated, Check records?
	36	Are sewage, trash, etc. disposal system adequate?
	37	Are Proper log maintained& available of all Rejected material in Rejected area room?
	38	Are there any insects (Flies, mosquito’s, etc.) in the buffer zone?
	39	Do the change rooms are neat & maintained properly?
	40	Do Batch Staging Area have a yellow Line?
	41	Do Calibration records are Available for Weight Boxes?
	42	Do all Weights are Shrink Wrapped?
	43	Are there any Dust found in Waste bins?

Annexure-I (b)

Audited Department : Auditor : Audit Date :
Inspection Check List for Documentation / Quality Assurance
S. No.	CHECKLIST	REMARKS
1	Are master copies of all the SOPs kept lock & Key?
2	Are process deviations recorded? i. Is the disposition of deviation being done by department head of QA? ii. Are corrective actions taken and recorded?
3	Does the current lists of all the SOPs available? i. Verify the master copies of SOPs. ii. Verify the SOP distribution and retrieval record. iii. Are superseded / obsolete SOPs marked accordingly and preserved separately. Choose any 3 current SOPs and / verify the status of their obsolete SOPs
4	Are the changes in the process, documents introduces as per controlled procedure? i. Is the record for change control maintained? ii. Is the disposition of change control done by department head of QA?
5	Is the current list of approved vendors available? i. Is the list of vendor’s segregated material wise? ii. Are the vendors approved by QA verified the records?
6	Is the list of RM / PM available & verify the code numbers?
7	Are market complaints processed and recorded by QA? i. Verify from the records and check the action taken on any 3 complaints.
8	Does a person of QA Deptt. remain present at the time of dispensing of RM?
9	Have all the trainings been carried out as per schedule and their assessment records maintained properly?
10	Are the self-inspections carried out as per schedule and records maintained?
11	Are all the Batch Manufacturing Records reviewed by the QA Manager before release of the product for sale?
12	Are the manufacturing and packing processes checked during production?
13	Are the BMRs of manufactured product kept properly in the record room year-wise?
S. No.	CHECKLIST	REMARKS
14	Are the records maintained for the approval of formats?
15	Is a consolidated list of all the documents and records maintained, department-wise?
16	Is the Quality Policy available and displayed?
17	Is the current Quality manual available?
18	Is the current SMF available & verify that all the information provided in SMF is updated?
19	Is the organogram of the company available? i. Does the organization chart demarcates the key responsibilities? ii. Are all the functional areas headed by key persons with adequate qualification, experience and training?
20	Is the list of current technical persons/key persons available for QC, Production, QA, Stores and Warehouse?
21	Are the copies of current manufacturing licenses available?
22	Is the list of all the products available? i. Verify the code numbers. ii. List of products for pharma market. iii. List of products for export market.
23	Does the current lists of specification / STPs for raw materials, finished products available? i. Verify the master copies of specification / STPs. ii. Verify specification / STP distribution and retrieval record. iii. Are superseded / obsolete specifications / STPs marked accordingly and preserved separately? Choose any 3 specification / STPs and verify the status of obsolete specifications / STPs.
24	Are Master formulae record available for all the products? i. Check the list of current MFRs. ii. Choose any 2 products and verify the Master formula records. iii. Are the master formula records authorized? iv. Does MFR includes expected final yields and intermediate yields?
25	Are batch manufacturing records (BMRs) issued and controlled as per the SOP? i. Choose any 4 products and verify the status of BMRs ii. Check the BMRs for any deviation or discrepancy.

Annexure-I (c)

Audited Department : Auditor : Audit Date :
Inspection Check List for Personnel
S. No.	CHECKLIST	REMARKS
1	Verify if the list of employees is current.
2	Is there a SOP for induction program of new recruits, Check records.
3	Verify if responsibilities of key personnel’s are clearly designated and documented.
4	Check induction and medical records of new joinee, select any 2 or 3 employees.
5	Check the availability of a qualified medical practitioner.
6	Mention the schedule for medical examination.
7	Choose 2-3 employees from each section/dept. verify the following: Health records, medical leave records
8	Verify whether a system exists for re-examination of an employee returning after a long medical leave by the company designated medical practitioner.
9	Is the training imparted for SOPs, GMP etc. i. Check staff training records. ii. Check external trainers record and verify the attendance through staff training records iii. Is the training literature and material preserved
10	Have employees’ undergone training on GMP, SOP and on job requirements, Are records available?
11	Verify training recording of three personnel.
12	SOP and training of personnel available. Is the relevant information like study material, attendance record, evaluation record, re-training record etc available.
13	Is the list of current technical persons available?
14	Is a list of personnel and the responsibilities available?
15	Is the first aid box provided at all the key locations?

Annexure-I (d)

Audited Department : Auditor : Audit Date :
Inspection Check List for Premises including personnel facilities & Sanitation / Housekeeping
S. No.	CHECKLIST	REMARKS
1.	Is the facility maintained in a clean and sanitary condition?
2.	Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
3.	Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?
4.	Verify, if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures?
5.	Does the facility have written procedures for the safe and correct use of cleaning sanitizing agent?
6.	Does the solution of cleaning and sanitation indicate rotation of Disinfectant If yes, check disinfectant inventory/ stock?
7.	Is the area outside the manufacturing area regularly got sprayed and record maintained?
8.	Are all the common Entry change Rooms cleaned as per daily schedule and record maintained?
9.	Are all the primary area change rooms cleaned properly and records maintained?
10.	Are all the secondary areas of all the sections cleaned regularly as per daily schedule and records maintained?
11.	Are all the lifts kept neat and cleaned?
12.	Are all the wash basins of all the change Rooms kept neat & clean?
13.	Is proper record maintained for the supply of factory uniforms to all the Employees?
14.	Check if cleaning records are maintained?
15.	Are the cleaning material kept at their proper places?
S. No.	CHECKLIST	REMARKS
16.	What is the level hygiene: Good (G)/Excellent (E)/Satisfactory (S)/Bad (B) (especially check nail, hair, etc.)
17.	Is each workers provided with two sets of uniforms/apparel Check records
18.	Are the gowning and degowning SOPs available and properly displayed in the change room?
19.	Is there a fixed schedule for washing of uniform? Check records.
20.	Are the workforce trained in personnel Hygiene is the training documented?
21.	Is the canteen or eating room facility neat and clean?
22.	Check if fire extinguishers are installed, checked, properly labeled and are fire safety drills performed as per schedule?
23.	Is written procedure describing safety measures is available?
24.	Are lighting and ventilation adequate to facilitate comfortable working?
25.	Check if the emergency exits in the building are maintained and unobstructed?
26.	Check if toilet cleaning and maintenance record are maintained, Availability of soap, hot and cold water air dryers, single service towels?
27.	Is waste being segregated as – plastics, organic, metal etc.?

Annexure-I (e)

Audited Department : Auditor : Audit Date :
Inspection Check List for Maintenance of buildings and Equipments / Engineering Services
S. No.	CHECKLIST	REMARKS
1.	Are written procedure established for maintenance of equipment and utilities?
2.	Are utilities maintain and monitored as per schedule?
3.	Is the preventive maintenance of major utilities being performed? a) Air Handling Units (AHUs) b) Compressed Air c) Vacuum Pump d) Air Conditioners e) Chiller Plant f) DG sets g) Boiler
4.	Does the filters in compressed air units are cleaned as per schedule? Check the SOP & records.
5.	Does the filters and prefilters in AHU system are cleaned as per schedule? Check the SOP & records.
6.	Is the cleaning procedure available for? a) Cooling towers b) Chiller plant c) Air handling units / duct / dampers d) Raw / DM Water storage tanks
7.	Are the service pipes clearly marked & indicate direction of flow (air, water, vacuum, LPG, Compressed Air)?
8.	Is there a schedule for the maintenance of service pipes? If yes, check the records.
9.	Is there a SOP on building maintenance? If yes, check the records?
10.	Does calibration planner is available and check for the compliance?
11.	Is the preventive Maintenance of all the Machine done according to their preventive maintenance schedule and records maintained?
S. No.	CHECKLIST	REMARKS
12.	Is the proper record regarding re-filling and monthly verification of conditions of Fire Extinguishers installed at various places maintained properly?
13.	Is the record of breakdown of machines maintained properly?
14.	Are the STP & ETP logbooks maintained?
15.	Are the Logbooks of all the DM Water tanks maintained?
16.	Are the Logbooks of all the Air Compressors maintained?
17.	Is the Logbook of the Electricity Meter Reading maintained?
18.	Are the Logbooks of Operation & service of Generators maintained?
19.	Is the Logbook of Operation & service of Boiler maintained?
20.	Is the Logbook of DM Water Plant Charging maintained?
21.	Is the list of critical spare parts for all the machines / equipment’s available? a) Check the list of critical spares for equipment; one each from production and utility. b) Check the stock ledger for the spare parts.
22.	Is the validation / calibration of equipment’s / guages performed as per schedule i) Check the validation / calibration records of minimum three equipment a)………………………………………….. b)………………………………………….. c)…………………………………………..
23.	Is the annual maintenance contract (AMC) / agreement available for the equipment which are not covered under preventive maintenance schedule?
24.	Check the record for job orders received and executed?

Annexure-I (f)

Audited Department : Auditor : Audit Date :
Inspection Check List for Equipment
S. No.	CHECKLIST	REMARKS
1.	Does all equipments used for manufacturing / processing are suitable in their size / capacity?
2.	Are the location of the equipment / machines in the facility acceptable?
3.	Is there adequate space for the following equipments? blender(s) dryer, compression machine(s) capsule fillers, bottle fillers etc.
4.	Are the equipment / machines properly design and installed?
5.	Are machine surfaces that direct contact the materials or finished goods non-reactive, non-absorptive and non-adaptive so as not to affect the product?
6.	Is the ideal equipment stored in a designated area?
7.	Is equipment cleaned promptly after used?
8.	Are written operating procedures available for each equipment used in manufacturing / processing or holding of components, in process material or finished product?
9.	Does the startup procedure ensure that equipment is thoroughly cleaned?
10.	Are all equipments have an identification no.?
11.	Do the major equipment have usage logs, cleaning logs, preventive maintenance logs?
12.	Are the relevant components of the machines calibrated and records maintained?
13.	Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
14.	Does the filters in the inlet of FBD are cleaned as per schedule? Check the SOP.

Annexure-I (g)

Audited Department : Auditor : Audit Date :
Inspection Check List for Production and In-process Control
S. No.	CHECKLIST	REMARKS
1.	Is the entry to the production area restricted?
2.	Are the work force trained in gowning / degowning / personnel hygiene / SOP / GMP etc? Check compliance to SOP
3.	Are production personnel attired as per SOP?
4.	Does complete set of SOPs available. Is it current?
5.	Verify the list of equipment and their identification codes.
6.	Is the BMR approved by QA prior to submission in doc cell?
7.	Check a current batch record from the shop floor.
8.	Are raw and packaging material tags attached in the BMR?
9.	Are the environmental conditions in different areas being monitored, maintained and recorded?
10.	In case of failure is the concerned department informed. Are the corrective actions documented?
11.	Is the impact of such environmental failure evaluated for impact on product?
12.	Is the procedure for line clearance followed? Question people regarding pack up at the end of shift or otherwise.
13.	Are the line clearance records being attached with the respective BMR?
14.	Does the machine indicate batch details and stage of processing of the batch?
15.	Are the in process checks being verified by IPQA personnel along with production personnel?
16.	Are the technical instruction being followed and entries being made in it, simultaneously?

S. No.	CHECKLIST	REMARKS
17.	Is there a procedure for issue, use and destruction of rubber stereos for coding during labeling and packing operations?
18.	Before the start of coding, are all specimens approved by IPQA?
19.	Are the approved specimen attached in the BMR of the product?
20.	How are coded unused material handled. Ask the manufacturing and packing supervisor?
21.	Are the labeling and packaging lines appropriate?
22.	Are there any physical separation between packaging lines?
23.	Is one product being processed in particular area?
24.	Is the wash water concept used for equipment?
25.	Are the washed and cleaned containers and machinery stored properly when not in use ?
26.	Is the procedure for process deviation implemented? Check records.

Audited Department : Auditor : Audit Date :
Inspection Check List for Oral Liquids Preparation Section
S. No.	CHECKLIST	REMARKS
a)	MANUFACTURING
	Is there any material without label?
	Is every machine / equipment labelled with correct status?
	Are operators wearing: a) Factory uniform properly b)Gloves/Masks c) Foot wears
	Whether the Operation & Cleaning log books for the following maintained & updated: a) Sugar Syrup: i. Mfg. Tank ii. Storage Tank iii.Transfer Tank b)Batch Room: i. Compounding Tank ii. Storage tank for Bulk Products iii. Filter Press
	Is the batch record compiled concurrently?
	Are there any Raw Materials present in the department which belong to two different products?
b)	BOTTLE FILLING LINE-I
	Is there any packing / raw material or finished goods belonging to other products present in the department?
	Does the filling machine bear appropriate label?
	Has the filling machine been cleaned before commencement of filling?
	Is the fill volume checked?

S. No.	CHECKLIST	REMARKS
c)	BOTTLE FILLING LINE-II
1.	Is there any packing / raw material or finished goods belonging to other products present in the department?
2.	Does the filling machine bear appropriate label?
3.	Has the filling machine been cleaned before commencement of filling?
4.	Is the fill volume checked?
d)	BOTTLE PACKING LINE-I
1.	Is there any material or container without proper label?
2.	Is the room clean and free of any evidence of other product?
3.	Whether all the details in packing record are being entered at appropriate timings?
e)	BOTTLE PACKING LINE-II
1.	Is there any material or container without proper label?
2.	Is the room clean and free of any evidence of other product?
3.	Whether all the details in packing record are being entered at appropriate timings?
f)	MISCELLANEOUS
1.	Is the line clearance procedure being followed?
2.	Are Cleaning log-books maintained separately for : a) Batch Room b) Primary Area Line-I c) Primary Area Line-II d) Secondary Area Line-II e) Secondary Area Line-II

Audited Department : Auditor : Audit Date :
Inspection Check List for Aseptic Section
S. No.	CHECKLIST	REMARKS
a)	COMPONENT PREPARATION AREA
1.	Is decartoning of Vials / Ampoules done in separate decartoning rooms?
2.	Are footwears and uniforms dedicated to components preparation area?
3.	Is record of compressed air filters cleaning maintained?
4.	Is record for DM water filters cleaning maintained and updated?
5.	Is SOP for vials / Ampoules washing machine operating instructions written?
6.	Are operators using hand gloves?
7.	Are operators trained for the job?
b)	COMPOUNDING
1.	Is batch preparation record compiled concurrently?
2.	Is the materials weighing done in compounding room?
3.	Is compounding room part of Sterile Block?
4.	Are footwears and uniforms dedicated to compounding room?
5.	Check the area and method of collecting distilled water for batch compounding.
6.	Are log books for Operation and Cleaning of compounding tanks maintained & updated?
7.	Is SOP of tank calibration written?
8.	Are masks worn by compounding personnel?
9.	What is the method of make-up the final volume?
10.	Is the compounding tank itself used as a pressure vessel for sterile filtration?
c)	STERILE FILTRATION
1.	Method of sterilizing membrane filter- Autoclaving / Dry heat
2.	Is sterilization indicator used?
3.	Is date of sterilization written?
4.	How are sterile membranes stored?

S. No.	CHECKLIST	REMARKS
5.	Is bubble point test of the membrane filters done before and after filtration?
6.	Adequacy of storing sterile filtered bulk solution?
7.	Is HEPA filter tested for DOP test?
d)	DRY HEAT STERILIZATION
1.	Check the loading pattern of S.S. boxes.
2.	How sterilized materials are stored?
e)	AUTOCLAVE STERILIZATION
1.	Condition of sterilizing equipment?
2.	Are log-books for Operation & Cleaning of both the Autoclaves maintained and updated separately?
3.	Is proper procedure followed for sterilization of rubber stoppers?
4.	How sterilized materials are stored in sterile area?
5.	Are sterilization indicators used?
f)	SEALING OF VIALS
1.	How seals are placed on the stoppered vials?
2.	Any stoppers found popped up in vials before placing seals?
g)	VISUAL INSPECTION OF VIALS/AMPOULES
1.	Is classification of optical reject done?
2.	How different products and batches are segregated?
3.	Where rejected vials are stored after completion of inspection?
4.	Is inspection of Vials / Ampoules done by rotation of workers?
5.	Are optically good vials and rejected vials segregated during optical inspection?
6.	Have all the operators undergone eye-check up?
h)	LABELLING
1.	Is overprinting done in-house? If it is in house, check overprinting area and comment
2.	Is labelling & packing done in one room?
3.	If No. 2 is yes, how segregation of batches and product done?
4.	How balanced packing materials are destroyed?

	S. No.	CHECKLIST	REMARKS
	i)	PACKING
	1.	Check packing records at random.
	2.	Line clearance for batch / product changeover SOP.
	3.	Is pack profile for all products available?
	j)	NON-VIABLE PARTICULATES MONITORING
	1.	What is the maximum temperature in filling rooms?
	2.	What is the humidity in filling room?
	3.	Is humidity meter calibrated using a sling psychrometer?
	4.	Comments about sterile area facility
	5.	Are all HEPA filters tested for integrity?
	6.	Are HEPA filters tested for integrity by DOP Test / Particle counter / both?
	7.	Check the air flow direction report
	8.	Have Rooms been monitored for direction of air flow?
	k)	VIABLE PARTICLE MONITORING OF STERILE AREAS
	1.	What is the size of Petri dishes used?
	2.	Which media is used to prepare Petri dishes?
	3.	Are plates preincubated?
	4.	Check locations of plate exposure
	5.	How many plates are exposed per room?
	6.	What is the duration of plate exposure?
	7.	Which rooms are monitored?
	8.	Are Rodac contact plates used or swabs are used?
	9.	If swabs are used, what is the sterilization procedure?
10.		Is alternate testing media used any time for sterile area monitoring?
l)		TRAINING
1.		Are operators training program record maintained?
2.		Is supervisors training programme record maintained?

Audited Department : Auditor : Audit Date :
Inspection Check List for Tablet Section
S. No.	CHECKLIST	REMARKS
1.	Are the equipments cleaned properly after change of product / Batch?
2.	Are log books for operation and cleaning of Equipments/Machines maintained separately and properly and also updated?
3.	Do all the equipments bear status labels?
4.	Are the following In-process tests performed by the Asstt. Mfg. Chemist and QA Officer and record maintained? a) Weight Variation b) Disintegration time c) Hardness d) Friability
5.	Is primary area neat and clean and cleaning log book maintained?
6.	Is secondary area neat and clean and cleaning log book maintained?
7.	Is Batch coding of strip / foil checked the Asstt. Mfg. Chemist and QA Officer and record maintained?
8.	Are strips checked for leakage?
9.	Are the balances calibrated and record maintained?
10.	Do all the containers bear status labels?
11.	Are the tablets visually inspected before packing?
12.	Is primary area neat and clean and cleaning log book maintained?
13.	Are the AHU filters cleaned as per schedule and record maintained?

Audited Department : Auditor : Audit Date:
Inspection Check List for Capsule Section
S. No.	CHECKLIST	REMARKS
1.	Is primary area neat and clean and cleaning log book maintained?
2.	Is secondary area neat and clean and cleaning log book maintained?
3.	Are log books for operation and cleaning of all the Machines/Equipments maintained separately and updated?
4.	Are the humidity and temperature controlled in the following rooms and record maintained? a) Batch Manufacturing Room b)Filling Room c) Polishing Room d) Primary packing Room
5.	Are the following In-process tests performed? a)Weight variation b) Disintegration time c)Leak test
6.	Are the balances calibrated and records maintained?
7.	Do all the equipments bear proper status labels?
8.	Is AHU filter cleaning record maintained?

Audited Department : Auditor : Audit Date :
Inspection Check List for Syrup Section
S. No.	CHECKLIST	REMARKS
1.	Are primary areas neat and clean and cleaning log book maintained?
2.	Are secondary areas neat and clean and cleaning log book maintained?
3.	Are log books for operation and cleaning of all the Machines/Equipments maintained and updated?
4.	Are the humidity and temperature controlled in the following rooms and record maintained? a)Batch Manufacturing Room b) Filling Room
5.	Are the following In-process tests performed by the Asstt. Mfg. Chemist and QA Officer and record maintained? a)Weight variation b) Disintegration time c)Leak test d) Sealing of bottles
6.	Are the balances calibrated and records maintained?
7.	Do all the equipments bear proper status labels?
8.	Is batch coding checked?
9.	Is AHU filter cleaning record maintained?

Audited Department : Auditor : Audit Date :
Inspection Check List for External Powders Section
S. No.	CHECKLIST	REMARKS
a)	MANUFACTURING
1.	Is there any material without label?
2.	Is every machine / equipment labelled with correct status label?
3.	Are operators wearing : a) Factory uniform properly b) Gloves/Masks c) Foot wears
4.	Is the weighing balance serviced / calibrated?
5.	Is the batch record compiled concurrently?
6.	Are there any Raw Materials present in the department which belong to two different products?
7.	Are the SOP for the following maintained and updated: a) Cleaning of Blender during product changeover. b) Operation of Powder Filling Machine
b)	a) B BOTTLE FILLING
1.	Is there any packing / raw material or finished goods belonging to other products present in the Filling Room?
2.	Does the filling machine bear appropriate label?
3.	Has the filling machine been cleaned before commencement of filling?
4.	Is the fill weight checked by the Asstt. Mfg. Chemist and QA Officer and record maintained?

S. No.	CHECKLIST	REMARKS
c)	BOTTLE PACKING
1.	Is there any material or container without proper label?
2.	Is the room clean and free of any evidence of other product?
3.	Whether all the details in packing record are being entered at appropriate timings?
4.	Are the cleaning log books for the following maintained and updated: a) Primary Area b) Secondary Area
5.	Is the line clearance procedure being followed?

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SOPs

To restrict entry of unauthorized Person in the Store

March 20, 2022February 6, 2023 ABHA

To restrict entry of unauthorized Person in the Store

Objective

To lay down a procedure to restrict entry of unauthorized Person in the Store.

Scope

This Standard Operating Procedure is applicable at Store at formulation plant

Responsibility

Store in-charge/personnel shall be responsible to follow and implementation of the procedure mentioned in this SOP.

Accountability

Store Incharge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA : Quality Assurance
Deptt. : Department

Procedure

List of Authorized persons to enter in store duly approved by QA shall be displayed on the front main gate of the store.
Indicate “ENTRY RESTRICTED” on the entry doors of all the store areas with paint.
Anyone who is not authorized cannot enter the warehouse area with authorized person without any valid reason
Properly lock the store.
Open the lock when required only in the presence of store personnel.
It is necessary for the person who is entering the store to wear the protective garments.
In Raw Material Store, shift the required raw material in the dispensary in the presence of store personnel and lock the store immediately. Return the material containers from the dispensary to the store after completing the process.
In Packing Material Store, transfer the required Packing Material to the production in the presence of store personnel and again lock the store immediately. Return the excess packing material from the production to the packing material store after completing the process.
In Finished Goods Store, transfer the required Finished Goods dispatched from the store under supervision of store personnel and again lock the store immediately.
The store personnel shall keep the keys of store very carefully with full responsibility.

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy – Quality Assurance
Controlled copies – Quality Assurance, Store

History

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SOPs

Operation and Cleaning of Sampling Booth

March 16, 2022February 6, 2023 ABHA

Operation and Cleaning of Sampling Booth

Objective

To lay down a procedure for the Operation and Cleaning of Sampling Booth.

Scope

This SOP is applicable for Operation and Cleaning of Sampling Booth of warehouse

Responsibility

Operator / Technician – For Operation and Cleaning of sampling Booth.
Warehouse Officer / Executive – To maintain proper functioning of the equipment & procedure as per the SOP.

Accountability

Warehouse Department In charge & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

QA : Quality Assurance
WH : Warehouse
RM : Raw Material
SOP : Standard Operating Procedure
API : Active Pharmaceutical Ingredients
IPA : Iso Propyl Alcohol

Procedure

Operation of Sampling Booth

Before starting the sampling activity, warehouse and QC personnel or their trained personnel must ensure the following:
Area and equipments are cleaned.
Temperature and Relative Humidity of sampling area are within the specified limit.
All the log books of the respective areas are updated.
The RLAF i.e. “Reverse Laminar Air Flow” is switched “ON” 15-20 minutes before the sampling activity starts.
Verify the pressure differential across the HEPA filter.
After achieving required differential pressure of gauge then allow to further activity.
After completion of activity switch off the RLAF.

Procedure for cleaning of Sampling Booth:

Check the electric supply of RLAF is switched-off.
The Pre Filter, HEPA Filter grills, SS table and floor of sampling area shall be cleaned.
Wipe from top to bottom S.S. grills or metal surfaces, balances etc. with a cleaned wet lint free cloth wet with 70% v/v IPA.
Mop the entire floor with lint free cloth wetted with disinfectant solution rotated weekly. Finally wipe entire floor with dry lint free mop.
For cleaning of supply Filter & Riser Filter, first dismantle the filter, cover it in polybag and transfer to washing area and then clean with water and dry with compressed air.
Record the details of operation and cleaning activities.

Cleaning Frequency:

Cleaning activity shall be done after completion of the sampling activity.
Pre-Filter of RLAF (Sampling booths) shall be cleaned on after every sampling.
If the Differential pressure across the limit inform to engineering department.
The Riser /Supply Filters shall be cleaned fortnightly by store department.
If any maintenance activity is performed in sampling area then clean the sampling area as per the cleaning procedure.

Forms and Records (Annexures)

Filter Cleaning Logbook – Annexure-I

Distribution

Master copy – Quality Assurance
Controlled copies – Quality Assurance, Raw Material Store.

History

Annexure-I

Filter Cleaning Logbook

	Prepared by	Checked by	Approved by
	Prepared by	Checked by	Deptt. Head	Head QA
Sign & Date
Name
Designation
Effective Date: Next Review Date:

Location:

Sr.No.

Date

Filter ID No.

Pressure Drop Before Cleaning

Cleaning Time

Pressure Drop After Cleaning

Cleaned By

Checked By

Remarks

HEPA Filter

(Limit-7.0-10.0 MMWC)

From

HEPA Filter

(Limit- 7.0 – 10.0 MMWC)

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SOPs

Cleaning of Dispensing and Sampling Tools

March 15, 2022February 6, 2023 ABHA

Cleaning of Dispensing and Sampling Tools

Objective

To lay down a procedure for Cleaning of Dispensing and Sampling Tools after dispensing and sampling activities respectively.

Scope

This standard operating procedure is applicable for Cleaning of Dispensing and Sampling Tools

Responsibility

Trained Worker shall be responsible for cleaning of Dispensing/Sampling Aids.
Store & QC personnel shall be responsible for checking of dispensing and sampling tools cleanliness as per SOP.

Accountability

Store In charge, Quality Control Head and Quality Assurance Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

SOP : Standard Operating Procedure
Sampling Tools : All the devices used for the sampling purpose i.e. Spatulas, Spoons and Sampling Rod etc.
IPA : Iso Propyl Alcohol

Procedure

After dispensing or sampling activities, wrap the tools with butter paper / polyethylene sheet along with “TO BE CLEANED” label and transfer to washing area.
Clean the total surface of tools with running potable water.
Finally rinse with purified water.
Allow to drain the water from the tools and wipe with clean wet (with 70% IPA) lint free cloth. Wipe the tools with clean, dry lint free cloth.
Check visually for the cleaning of the device and re-clean if required / found dirty.
After dispensing/sampling of each batch, the above mentioned cleaning procedure for dispensing and sampling tools shall be followed.
The cleaned sampling device shall be wrapped with clean aluminum foil/butter paper/polythene.
After cleaning ‘Cleaned Label’ shall be affixed.
The cleaned sampling device shall be kept in respective areas.
The cleaning details shall be recorded as per Annexure – I.
The cleaned sampling device shall be used within five days. If not, re-cleaning shall be done.

Forms and Records (Annexures)

Cleaning Record of Dispensing & Sampling Tools – Annexure I

Distribution

Master copy – Quality Assurance
Controlled copies – Stores, Quality Control, Quality Assurance

History

Annexure I

Cleaning Record of Dispensing & Sampling Tools

	Prepared by	Checked by	Approved by
	Prepared by	Checked by	Deptt. Head	Head QA
Sign & Date
Name
Designation
Effective Date: Next Review Date:

AREA: Dispensing Booth (ID No. ______________) / Sampling Booth (ID No. __________)

Date	Product Name	Batch No.	Dispensing / Sampling Tools	Done by	Checked by	Remarks

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Reason for Revision

To restrict entry of unauthorized Person in the Store

Operation and Cleaning of Sampling Booth

Cleaning of Dispensing and Sampling Tools

Do Not Sell My Personal Information