Terms and Conditions

PROCEDURE FOR LINE CLEARANCES

Byiamraj

Nov 19, 2020 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

PROCEDURE FOR LINE CLEARANCES

OBJECTIVE: To ensure that the area, equipment and activities required for the manufacturing and packing of pharmaceutical products are free from any potential sources of cross contamination / mix-ups (Line clearance).

2.0 SCOPE: The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities.

3.0 Responsibility : In – process quality Assurance Executive/Officer.

4.0  ACCOUNTABILITY:

Quality Assurance Manager.

5.0  PROCEDURE

5.1 Verify the following points before giving clearance for activity which has to be started after it has been checked by Production Executive / Officer in dispensing and manufacturing area.

5.1.1 Machine status for cleanliness and cleaned label is affixed.

5.1.2 Area status for cleanliness including dust bins, walls, return raisers.

5.1.3 Status labels of Bins, IPCs, Sieves, equipments, RLAF etc. to be used during manufacturing.

5.1.4 Release status of the product till the previous stage if applicable.

5.1.5 Calibration status of weighing balances.

5.1.6 Batch details of the product to be started should be displayed on the display board.

5.1.7 Rh, temperature and pressure differential of that particular room in which activity has to start along with the pressure differential of RLAF (If applicable).

5.1.8 Clearance by swab analysis in case of product changes over.

5.2    For Activities in Dispensing Area 

5.2.1 After verification of Point Nos. 5.1.1 to 5.1.8, check the materials to be dispensed.

5.2.2 The raw materials should be approved by QC.

5.2.3 Verify the calculations for dispensing in the BMR.

5.2.4 The ‘Cleaned’ tags shall be signed by IPQA Officer / Executive at the start of the activity as a verification. This shall mean that line clearance has been given for dispensing.

5.2.5 Line clearance in BMR can either be given by Production or IPQA officer / Executive.

5.3    For Activities in Manufacturing Area 

5.3.1  After verification of Point Nos. 5.1.1 to 5.1.8, check the batch record completion till previous stage.

5.3.2  The ‘Cleaned’ tags shall be signed by IPQA Officer / Executive at the start of the activity as a verification. This shall mean that line clearance has been given to a particular process.

5.3.3 Line clearance in BMR can be given either by Production or IPQA officer / Executive.

5.4    For Filling and Compression

  • After verification of Point Nos. 5.1.1 to 5.1.8, the initial checks for capsules filling or tablets compression shall be carried out.

5.4.2  If these checks are found satisfactory, the line clearance shall be given.

5.4.3 ‘Recoverable’ tags shall be signed by Production as well as IPQA Officer / Executive for that particular batch.

5.4.4  ‘Non – recoverable’ tags shall be signed by Production Officer / Executive at the time of start and IPQA Officer/  Executive shall sign it after completion of the batch.

5.5   For Primary Packing 

5.5.1 Check the Rh, temperature and pressure differential of that particular room in which activity has to start.

5.5.2 Machine status for cleanliness for each machine like Blister packing machine, Strip packing machine etc.

5.5.3 In case a different product is to be started, make sure that the machine change over is completed and the machine is clean and no previous product leftover.

5.5.4 Check the area cleanliness, belt and conveyor cleanliness.

5.5.5 Ensure that no trace of any material of the previous product is present in the area and machine parts.

5.5.6 Ensure the following details of the batch to be packed:

  • Batch Number
  • Manufacturing Date
  • Expiry Date
  • CST recoverable (If applicable)
  • Registration Number (If applicable) and
  • Retail Price (If applicable)

5.5.7 The product to be started is mentioned on the display board along with the batch size, Pkg. Qty., and other details as per Point No. 5.5.6

5.5.8  Approved primary packaging components are present.

5.5.9  Specimen of label / Foil / Carton are available and they are duly signed by Production Officer / Executive with details as per point No. 5.5.6.

5.5.10  The specimen shall be verified with BPR for details as mentioned in 5.5.6.

5.5.11   Recoverable’ tags shall be signed by Production as well as IPQA Officer / Executive for that particular batch.

5.6        For Secondary Packing 

5.6.1     After verification from Point Nos. 5.5.4 to 5.5.10, counter sign the ‘Line Clearance’ at the start of the activity as  verification. This shall mean that line clearance has been given to the particular process.

5.6.2   Sign the ‘Line Clearance’ tags and in BPR at appropriate places.

5.6.3 In case if manual coding is to be carried out, for labels and / or cartons, the line clearance shall be given according to Point No. 5.1.4 and Point Nos. 5.5.4 to 5.5.10.

5.6.4  Ensure balances are in calibration state and leveling done.

Attachments – I

Line Clearance Checklist

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous Product:   Batch No.  :  

Dispensing Room:

Sr. No. Check points

Observations

Done

By

Checked by Verified

By QA

Production Warehouse
DISPENSING AREA [Released / Not Released / Hold / Rejected / Not Applicable]
Room Identification number:
1 Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.          
2 Ensure updation of status board & ‘CLEANED’ label is affixed on each equipment.          
3 Cleanliness of Supply Air Grills of AHU.          
4 Cleanliness of Return Air Grills of AHU.          
5 Cleanliness of floor, ceiling, walls, drainage, light fixtures, dustbins, containers, tools, vacuum cleaner.          
6 Area surrounding the dustbins, containers, tools and Balances.          
7 Temperature [24 ± 2°c]          
8 Relative Humidity [35 – 50 %]          
9 Differential Pressure [10 – 26 Pascal]          
10 Updation on status board          

Dispensing Booth: 

Sr. No. Check points  Observations  Done

 By

Checked by  Verified  

By QA

Active Excipient Colour Production Warehouse
Room Identification number:
1 Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.              
2 Ensure updation of status board/ status label on RLAF.              
3 Ensure ‘CLEANED’ label is affixed on each cleaned equipment/tools/balances/IPC/Bins.              
4 Cleanliness of Supply Air Grills of RLAF.              
5 Cleanliness of Return Air Grills of RLAF.              
6 Cleanliness of floor, RLAF walls, light fixtures, containers, tools and balances.              
       7 Calibration of balances              
8 Pressure differential across pre-filters.              
9 Pressure differential across HEPA filters.              

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 Vacuum cleaner: 

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Vacuum cleaner Equipment ID No.: ____________________

q Ensure the absence of batch documents, labels, powder, materials or remnants of previous product or batch.

q Area surrounding the Equipment

   
CLEANLINESS OF

q Hose Pipe

q Dust resisting filter

q Dust Collecting Bag

q Cleaned Label Present

 

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

BINDER PREPARATION [Released / Not Released / Hold / Rejected / Not Applicable]
Binder Preparation Area Room ID: ____________________

Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls                               Ceiling

Drain

Supply air Grills

Containers

Tools

Vacuum cleaner

Waste Bins

Light Fixtures

Return air Grills

Steam Jacketed Vessel Equipment ID: ____________________

CLEANLINESS OF

Ensure the absence of batch documents, labels, materials, paste, traces of water or remnants of previous product or batch.

Cleaned Label Present

Area surrounding the Equipment

       
GRANULATION [Released / Not Released / Hold / Rejected / Not Applicable]
Granulation Area Room ID: _____________________

Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Supply air Grills

Return air Grills

Light Fixtures

Waste Bins

Container

Tools

Vacuum cleaner

q Area below the vibro Sifter.

q Area below the Turbo sifter

cum multimill.

Area below the FBD/FBP.

Area below the RMG

Area below Tippler

Area below OGB

Area below Ball mill

Area below oscillating Granulator

Area below the Quadroco

Mill

       Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Vibro Sifter Equipment ID No.: __________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Intermediate Hopper

Cleaned Label Present

Gasket Integrity

Sieve Integrity

Discharge Chute

Wheels

Feed Hopper

Rapid Mixer Granulator Equipment ID No.: ___________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Bowl

Mixer Cone

Chopper

Charging Port

Agitator

Mixer Base

Cleaned Label Present

 

Discharge Valve

Gasket Integrity

Arm

Drain

Lid

Column

Vent filter (Product Specific, if applicable)
 Turbo Sifter cum Multimill Equipment ID No.: ___________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       

  Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.  

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Turbo Sifter cum Multimill CLEANLINESS OF

Feed hopper

Blade assembly

Vent Filter

Wheels

Rotor

Gasket Integrity

Discharge Hopper

Cleaned Label Present

       
Quadracomill Equipment ID No.: __________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Feed Hopper

Discharge Assembly

Blade Assembly

 

Gasket Integrity

Wheels

Cleaned label present

Fluidized Bed Dryer/ Fluidized Bed Processor Equipment ID No.: _________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Gasket between the bowl & plenum

View glass integrity (intact)

Upper & lower Plenum

Product Bowl & Mesh.

Gasket integrity (intact)

Wheels of the bowl

Peristaltic Pump

Sampling Probe

Light assembly

Cleaned Label Present

Filter Bag

Retarding chamber

Exhaust end

Printer

Temperature probe

 

Tippler

 

Equipment ID No.: ________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Area surrounding the Equipment

       
CLEANLINESS OF

Stand

Cleaned Label Present

Cone

Valve

Gasket integrity

       

 Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Octagonal Blender Equipment ID No.: __________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Inside corners of the Blender

Cleaned Label Present

Rectangular Lid

Butterfly Valve

Top Closing Lid

Shaft & Baffles

Gasket Integrity

Ball mill Equipment ID No.: _________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Main chambers

Discharge Assembly

Ball Assembly

 

Gasket Integrity

Wheels

Cleaned label present

Oscillating Granulator Equipment ID No.: _________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Main chambers

Discharge Assembly

Wheels

Cleaned label present

Vacuum cleaner

 

Equipment ID No.: _________________

Ensure the absence of batch document, labels, powder,

materials or remnants of previous product or batch.

Area surrounding the Equipment

       
CLEANLINESS OF

Hose Pipe

Dust resisting filter

Dust Collecting Bag

Cleaned Label Present

 

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Weighing Balances Instrument ID No.: ______________

CLEANLINESS OF

       
Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

  Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

BLENDING [Released / Not Released / Hold / Rejected / Not Applicable]
Blending Area Room ID: _____________________

Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Tools

Area under the blender

Area under the vibro sifter

Supply air Grills

Return air Grills

Light Fixtures

Waste Bins

Vacuum cleaner

Octagonal Blender Equipment ID No.: __________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Inside corners of the Blender

Cleaned Label Present

Rectangular Lid

Butterfly Valve

Top Closing Lid

Shaft & Baffles

Gasket Integrity

Vibro Sifter Equipment ID No.: __________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Vibro Sifter CLEANLINESS OF

Feed Hopper

Sieve Integrity

Gasket Integrity

Cleaned Label Present

Intermediate Hopper

Discharge Chute

Wheels

       
Tippler Equipment ID No.: _________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Stand

Cleaned Label Present

Cone

Valve

Gasket integrity

Vacuum cleaner Equipment ID No.: __________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.

Area surrounding the Equipment

       
CLEANLINESS OF

Hose Pipe

Dust resisting filter

Dust Collecting Bag

Cleaned Label Present

 

Weighing Balances Instrument ID No.: _________________

CLEANLINESS OF

       
Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable]
Compression

Cubicle

Room ID: _____________________

Ensure the absence of batch documents, labels, materials, powder, tablets,  or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Tools

Waste Bins

Light Fixtures

Area under compression Machine

Area under the Deduster

Area under the Metal Detector

Area under the balances

Supply air Grills

Return air Grills

Vacuum cleaner

Compression Machine Equipment ID No.:__________________

Ensure the absence of batch documents, labels,  powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

All acrylic component integrity (intact)

Machine interior & hose pipes

Lower & Upper punch holes

Sleeve of the hopper

Forced Feeder assembly

Pressure Rollers

Discharge Chute

Lower & Upper cam tracks

Hopper

Turret

Die Cavities

Cleaned label present

Safety Guard

Dust Extractor Equipment ID No.: ________________

Ensure the absence of powder.

       
CLEANLINESS OF

Hose Pipe

Dust Collecting SS pipe

Cleaned Label Present

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Metal Detector Equipment ID No.: __________________

Ensure the absence of batch documents, labels,  powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Chute assembly

Cleaned label present

Rejection Flap

Rejection Container

Solenoid cover

Deduster Equipment ID No._________________

Ensure the absence of batch documents, labels,  powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Perforated Plate

Discharge Chute

Cleaned Label present

Vacuum cleaner Equipment ID No.: _________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.

Area surrounding the Equipment

       
CLEANLINESS OF

Hose Pipe

Dust resisting filter

Dust Collecting Bag

Cleaned Label Present

 

Weighing Balances Instrument ID No.: _________________

CLEANLINESS OF

       
Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

COATING [Released / Not Released / Hold / Rejected / Not Applicable]
Coating Room Room ID No.: ____________________

Ensure the absence of batch documents, labels, materials, powder, tablets,  or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Tools

Waste Bins

Light Fixtures

Area under coating Machine

Area under the Colloidal mill

Area under the coating solution

preparation tank

Area under the coating solution

storage tank

Area under the balance

Supply air Grills

Return air Grills

Auto-coater Equipment ID No.: ________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water or colour on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

       
CLEANLINESS OF

Exhaust hood

Base of the Dosing Pump

Cleaned Label Present

Connecting Pipes

View Glass Integrity (intact)

Temperature probe

Sampling Probe

Light assembly

Hot air blower

Spray Guns

Baffles

Cabinet

Pan

Spray gun Bar

PLC assembly

Peristaltic Pump

Colloid Mill Equipment ID No.: _________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch and traces of water or colour.

       

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Colloid Mill CLEANLINESS OF

Cleaned Label Present

Rotor

Hopper

Hose pipe

Stator

       
Weighing Balances Instrument ID No.: _________________

CLEANLINESS OF

       
Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

INSPECTION [Released / Not Released / Hold / Rejected / Not Applicable]
Inspection Area Room ID No.: ____________________

Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Light Fixtures

Tools

Waste Bins

Supply air Grills

Return air Grills

Area under Inspection Machine

Area under the balance

Inspection Machine Equipment ID No.: _________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch and traces of water or colour.

       
CLEANLINESS OF

Base of the belt

Illumination of the belt

Cleaned label present

Reject tray

Integrity of rollers

 Conveyor belt

Hopper

Tablet modifier

Inside the belt

Rollers

Manual Inspection Room ID No.: ____________________

Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

SS trays

Inspection Table

       
Weighing Balances Instrument ID No.: ________________

CLEANLINESS OF

       
Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

       Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

PACKING [Released / Not Released / Hold / Rejected / Not Applicable]
Packing Room Room ID No.: ____________________

Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

       
CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

q Light Fixtures

Tools

Waste Bins

Supply air Grills

Return air Grills

Area under packing Machine

Blister Packing Machine / Strip packing machine / Defoiling Machine Equipment ID No.: _________________

Ensure the absence of materials / Powder / tablets / Aluminum foil / PVC foil / PVDC foil / Printed foil / Strips / Blisters or remnants of previous product or batch & traces of water.

Pass box cleanliness.

Overprinting Stereos of previous batch or product are destroyed.

Area surrounding the Equipment

       

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

PACKING [Released / Not Released / Hold / Rejected / Not Applicable]
Packing Line Line No.: ____________________

Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

       

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Packing Line CLEANLINESS OF        
Floor

Walls

Ceiling

Container

Carets

 Tools

Waste Bins

Supply air Grills

Return air Grills

Light Fixtures

Conveyer Belt Equipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

       
Cartooning Machine Equipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

       
Online check weigher Equipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

       
Shipper sealing machine Equipment ID No.: __________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

       
Shipper weighing balance Equipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

       
Shipper strapping machine Equipment ID No.: __________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

       

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance. 

Dosage Form: Tablet Date / Time:  
Product:   Batch No.  :  
Previous product:   Batch No.  :  

 

  

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Manual Coding Room Room ID No.: ____________________

Ensure the absence of batch documents, labels, materials, or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed.

       
CLEANLINESS OF

Floor

Walls

Ceiling

Container

 Light Fixtures

Tools

Waste Bins

Supply air Grills

Return air Grills

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Packing Equipment ID No.: _________________

Approval of Intermediate product of current batch.

BMR of current batch completed up to previous stage.

Machine operation clearance.

       

 

 

By iamraj