PROCEDURE FOR LINE CLEARANCES

November 19, 2020December 31, 2023 ABHA

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
Sr. No.	Check points	Observations	Done By	Production	Warehouse	Verified By QA
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
Sr. No.	Check points	Active	Excipient	Colour	Done By	Production	Warehouse	Verified By QA
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.

SOPs Aberdeenshire, Abu Dhabi, Abu Dhalouf, Abu Hamour, Abu Samra, ABUJA, ACCRA, Acre, Ad Dawhah al Jadidah, ADDIS ABABA, Adelaide, AFGHANISTAN, Agra, Agrigento, Ahmedabad, Aïn Beïda, Ain Khaled, Ain Sinan, Ajman, Ajman and Ra’s al-Khaimah, Ajmer, Al Ain, Al Aziziya, Al Bidda, Al Daayen, Al Dafna, Al Ebb, Al Egla, Al Gharrafa, Al Ghuwariyah, Al Hilal, Al Jasrah, Al Jeryan, Al Karaana, Al Kharaitiyat, Al Kharayej, Al Kharrara, Al Kheesa, Al Khor, Al Khulaifat, Al Luqta, Al Mamoura, Al Mansoura, Al Markhiyah, Al Mashaf, Al Masrouhiya, Al Mearad, Al Messila, Al Mirqab, Al Najada, Al Nasraniya, Al Qassar, Al Rufaa, Al Sadd, Al Sailiya, Al Sakhama, Al Seej, Al Shagub, Al Souq, Al Tarfa, Al Thakhira, Al Themaid, Al Thumama (Al Wakrah), Al Thumama (Doha), Al Utouriya, Al Waab, Al Wajba, Al Wakrah, Al Wukair, Al Zubarah, Al-Shahaniya, Alagoas, ALBANIA, Alberta, Alessandria, ALGERIA, Algiers, Aligarh, Allahabad, Allerdale, Amapa, Amazonas, Amber Valley, Amersham, AMMAN, Ampthill, Amravati, Amritsar, Amsterdam, Amur, Ancona, and Craigavon, and Down, ANDORRA, ANDORRA LA VELLA, ANGOLA, Angus, ANKARA, Annaba, ANTANANARIVO, ANTIGUA & BARBUDA, Antrim and Newtownabbey, Antwerp, Aosta, APIA, Ar Ru'ays, Ards and North Down, ARGENTINA, Argyll and Bute, Arkhangelsk, Arlington, Armagh, ARMENIA, As Salatah, Ascoli Piceno, Ashbourne, ASHGABAT, ashington, Ashland, Ashmore and Cartier Islands, ASMARA, Asti, Astrakhan, ASUNCIÓN, Athens, Auckland, Aurangabad, AUSTRALIA, Australian Antarctic Territory, Australian Capital Territory, Austria, Avellino, Aylesbury, Aylesbury Vale, AZERBAIJAN, Baaya, BAGHDAD, BAHAMAS, Bahia, BAHRAIN, BAKU, BAMAKO, Banbridge, BANDAR SERI BEGAWAN, Bangalore, BANGKOK, BANGLADESH, Bangor, BANGUI, Bani Hajer, BANJUL, Barahat Al Jufairi, BARBADOS, Barcelona, Bareilly, Bari, Barletta-Andria-Trani, Barrow-in-Furness, BASSETERRE, Bath, Batna, Bavaria, Beaconsfield, Béchar, Bedford, BEIJING, BEIRUT, Béjaïa, Belarus, Belfast, Belgium, Belgorod, Belgrade, BELIZE, Belluno, BELMOPAN, Belper, Benevento, BENIN, Bergamo, Berlin, BERN, Bhavnagar, Bhilai Nagar, Bhiwandi, Bhopal, Bhubaneswar Salem, BHUTAN, Biella, Bikaner, Birmingham, Birmingham (West Midlands), BISHKEK, Biskra, BISSAU, Blackburn with Darwen, Blackpool, Blaenau Gwent, Blida, BLOEMFONTEIN, Bloomsbury, Bodmin, BOGOTÁ, BOLIVIA, Bologna, Bolsover, Bordj Bou Arreridj, BOSNIA & HERZEGOVINA, BOTSWANA, Bou Saâda, Bournemouth, Bracknell Forest, Bradford, BRASILIA, BRATISLAVA, BRAZIL, BRAZZAVILLE, Bremen, Brescia, Bridgend, BRIDGETOWN, Brighton, Brighton and Hove, Brindisi, Brisbane, Bristol, British Columbia, BRUNEI, BRUSSELS, Brussels-Capital Region, Bryansk, Bu Fasseela, Bu Samra, Bu Sidra, Bucharest, Buckinghamshire, Budapest, BUENOS AIRES, BUJUMBURA, Bulgaria, BURKINA FASO, Burlington, BURUNDI, Buxton, CABO VERDE, Caerphilly, Cagliari, CAIRO, Caltanissetta, CAMBODIA, Cambridge, Cambridgeshire, Camden, CAMEROON, Campobasso, canada, Canberra, Canterbury, CAPE TOWN, Cardiff, Carlisle, Carmarthenshire, Caserta, CASTRIES, Catania, Catanzaro, Causeway Coast and Glens, Ceara, Centerville, CENTRAL AFRICAN REPUBLIC, Central Bedfordshire, Ceredigion, CHAD, Chalfont St. Giles, Chandigarh, Charlottetown, Chelmsford, Chelyabinsk, Chennai, Cheshire East, Cheshire West and Chester, Chester, Chesterfield, Chichester, Chieti, CHILE, Chiltern, CHINA, Chlef, Christmas Island, City of London, Clackmannanshire, Clayton, Cleveland, Clinton, Clydebank, Coatbridge, Cockermouth, Cocos (Keeling) Islands, Coimbatore, Coldstream, COLOMBIA, COLOMBO, Como, COMOROS, CONAKRY, Congleton, CONGO, Constantine, Conwy, Copeland, Copenhagen, Coral Sea Islands, Cornwall, Cosenza, COSTA RICA, CÔTE D'IVOIRE(Ivory Coast), Coventry, Cremona, Crewe, CROATIA, Cromarty, Crotone, CUBA, Cumbernauld, Cumbria, Cuneo, Cuttack, CYPRUS, Czech Republic, CZECH REPUBLIC (Czechia), Dahl Al Hamam, DAKAR, Dalkeith, DAMASCUS, Darlington, Darwin, Dayton, Dehradun Garhwali, Delhi, Denbighshire, denmark, Derby, Derbyshire, Derbyshire Dales, Derry, Derry and Strabane, Devon, DHAKA, Djelfa, DJIBOUTI, DJIBOUTI (CITY), DODOMA, Doha, Dombivali, DOMINICA, DOMINICAN REPUBLIC, Donetsk, Dorset, Dover, dubai, Dublin, Duhail, Dukhan, Dumfries and Galloway, Dunbar, Dundee, Dunkeld, Duns, Dunstable, Durgapur Asansol, Durham, DUSHANBE, East Ayrshire, East Devon, East Dunbartonshire, EAST JERUSALEM, East Lothian, East Midlands, East of England, East Renfrewshire, East Riding of Yorkshire, East Sussex, ECUADOR, Eden, Edinburgh, Edmonton, EGYPT, El Eulma, El Oued, EL SALVADOR, Elgin, Ely, England, Enna, EQUATORIAL GUINEA, Erewash, ERITREA, Espirito Santo, Essex, estado, estados, ESTONIA, ESWATINI (formerly Swaziland), ETHIOPIA, Exeter, Fairview, Falkirk, Falmouth, Faridabad, Fenland, Fereej Abdel Aziz, Fereej Al Amir, Fereej Al Asiri, Fereej Al Asmakh, Fereej Al Manaseer, Fereej Al Murra, Fereej Al Nasr, Fereej Al Soudan, Fereej Al Zaeem, Fereej Bin Durham, Fereej Bin Mahmoud, Fereej Bin Omran, Fereej Kulaib, Fereej Mohammed Bin Jassim, Fermanagh and Omagh, Fermo, Ferrara, Fife, FIJI, Finland, Firozabad, Flintshire, Florence, Foggia, Forlì-Cesena, Forres, Fort William, Fowey, FRANCE, Frankfurt Rhine-Main Region, Franklin, Fredericton, FREETOWN SINGAPORE, Frosinone, Fujairah, FUNAFUTI, Fuwayrit, GABON, GABORONE, Galashiels, GAMBIA, Genoa, Georgetown, GEORGIA, Germany, GHANA, Gharrafat Al Rayyan, Ghaziabad, Glasgow, Gloucester, Gloucestershire, Goias, Gorakhpur, Gorizia, Grasmere, Greater Glasgow, Greater London, Greater Manchester, greece, Greenock, Greenville, GRENADA, Grosseto, GUATEMALA, GUATEMALA CITY, Guelma, GUINEA, GUINEA-BISSAU, Gujarati, Gulbarga, Guntur, Gurgaon, Guwahati, GUYANA, Gwalior, Gwynedd, Haddington, HAITI, Halifax, Halton, Hamad Medical City, Hamburg, Hampshire, Haora, HARARE, Hartlepool, HAVANA, Hawick, Hawke's Bay, Hazm Al Markhiya, Heard Island and McDonald Islands, Helsinki, Helston, Hereford, Herefordshire, Hertfordshire, Hesse, High Peak, High Wycombe, Highland, Hobart, HONDURAS, HONIARA, Hove, Hubli and Dharwad, Hudson, Hungary, Huntingdon, Huntingdonshire, hyderabad, ICELAND, Imperia, INDONESIA, Indore, Inverclyde, Invergordon, Inverness, Iqaluit, IRAN, IRAQ, ireland, Irkutsk, Irvine, Isernia, ISLAMABAD, Isle of Anglesey, Isle of Wight, Isles of Scilly, ISRAEL, Istanbul, Italy, Ivanovo, Izghawa (Al Rayyan), Izghawa (Umm Salal), Jabal Thuaileb, Jabalpur, Jackson, Jaipur, JAKARTA, Jalandhar, JAMAICA, Jammu, Jamnagar, Jamshedpur, JAPAN, Jelaiah, JERUSALEM, Jervis Bay Territory, Jeryan Jenaihat, Jeryan Nejaima, Jhansi, Jijel, Jodhpur, JORDAN, JUBA, KABUL, Kaliningrad, Kaluga, Kalyan, KAMPALA, Kanpur, KATHMANDU, Katowice urban area, KAZAKHSTAN, Kazan, Kemerovo, Kendal, Kent, KENYA, Keswick, Kharkiv, KHARTOUM, Khawr al Udayd, Kiev, KIGALI, Kingston, Kingston upon Hull, KINGSTOWN, Kinross, KINSHASA, KIRIBATI, Kirkintilloch, Kirkwall, Kirov, Knutsford, Kochi, Kolkata, KOSOVO, Kostroma, Kota, Kraków, KUALA LUMPUR, Kurgan, Kursk, Kuwait, KUWAIT CITY, KYRGYZSTAN, L'Aquila, La Spezia, Laghouat, Lancashire, Lancaster, LAOS, Latina, LATVIA, Launceston, Leabaib, Lebanon, Lebday, Lecce, Lecco, Leeds, Leicester, Leicestershire, Lejbailat, Lekhwair, Leningrad, Leqtaifiya (West Bay Lagoon), LESOTHO, Lexington, LIBERIA, LIBREVILLE, LIBYA, Lichfield, LIECHTENSTEIN, Lijmiliya, Lille–Kortrijk–Tournai France/ Belgium, LILONGWE, LIMA, Lincoln, Lincolnshire, Lipetsk, Lisbon, Lisburn, Lisburn and Castlereagh, LITHUANIA, Liverpool, Livorno, LJUBLJANA, LOMÉ, london, Loni, Looe, Lossiemouth, Lostwithiel, Luaib, LUANDA, Lucca, Lucknow, Ludhian, Lusail, LUSAKA, Luton, LUXEMBOURG, M'Sila, Macclesfield, Macerata, MADAGASCAR, Madinat Al Kaaban, Madinat ash Shamal, Madinat Khalifa North, Madinat Khalifa South, Madison, Madrid, Madurai, Magadan Moscow, Maghnia, MAJURO, MALABO, MALAWI, MALAYSIA, MALDIVES MALE, MALI, MALTA, MANAGUA, MANAMA, Manchester, MANILA, Manitoba, Mantua, Maranhao, Marlborough, Marlow, Marseille, Mascara, MASERU, Massa and Carrara, Matera, Matlock, Mato Grosso, Mato Grosso do Sul, MAURITANIA, MAURITIUS, MBABANE, Mebaireek, Médéa, Medway, Meerut, Mehairja, Melbourne, Merseyside, Merthyr Tydfil, Mesaieed, Mesaimeer, Messina, MEXICO, MEXICO CITY, Mid and East Antrim, Mid Ulster, Middlesbrough, Midlothian, Milan, Milford, Milngavie, Milton, Milton Keynes, Minas Gerais, Minsk, Modena, MOGADISHU, Monmouthshire, MONROVIA, MONTEVIDEO, Monza and Brianza, Moradabad, Moray, MORONI, Moscow, Mostaganem, Motherwell and Wishaw, Mount Vernon, Mourne, Muaither, Mumbai, Muraikh, Murmansk, MUSCAT, Mushayrib, Mysore, N'DJAMENA, Nagpur, NAIROBI, Najma, NAMIBIA WINDHOEK, Nanded Kolapur, Nantwich, Naples, Nashik, NASSAU, NAURU, Navi Mumbai, Neath Port Talbot, Nellore, Nelson, NEPAL, Netherlands, New Al Hitmi, New Al Mirqab, New Al Rayyan, New Brunswick, New Fereej Al Ghanim, New Fereej Al Khulaifat, New Plymouth, New Salata, New South Wales, NEW ZEALAND, Newfoundland and Labrador, Newport, NewportAuburn, Newquay, Newry, NGERULMUD, NIAMEY, NICARAGUA, NICOSIA, NIGER, NIGERIA, Nizhniy Novgorod, Nizhny, Noida, Norfolk, Norfolk Island, North, North Ayrshire, North East, North East Derbyshire, North East Lincolnshire, NORTH KOREA, North Lanarkshire, North Lincolnshire, NORTH MACEDONIA, North Somerset, North West, North Yorkshire, Northamptonshire, Northern, Northern Ireland, Northern Territory, Northumberland, Northwest Territories, Northwich, Norway, Norwich, Nottingham, Nottinghamshire, NOUAKCHOTT, Nova Scotia, Novara, Novgorod, Novosibirsk, Nu`ayjah, Nunavut, Nuoro, NUR-SULTAN, Nuremberg, Oakland, Old Al Ghanim, Old Al Hitmi, Old Al Rayyan, OMAN, Omsk, Onaiza, Ontario, OntarioToronto, Oran, Orenburg, Oristano, Orkney Islands, Oryol, OSLO, Otago, Ottawa, OUAGADOUGOU, Ouargla, Oxford, Oxfordshire, Padua, Paisley, PAKISTAN, PALAU, Palermo, PALESTINE, PANAMA, PANAMA CITY, PAPUA NEW GUINEA, Para, PARAGUAY, Paraiba, PARAMARIBO, Parana, Paris, Parma, Patna, Pavia, Pembrokeshire, Penrith, Penryn, Penza, Penzance, Pernambuco, Perth, Perth and Kinross, PERU, Perugia, Pesaro and Urbino, Pescara, Peterborough, PHILIPPINES, PHNOM PENH, Piacenza, Piaui, Pimpri, Pisa, Pistoia, Plymouth, Poland, Poole, Pordenone, PORT LOUIS, PORT MORESBY, PORT OF SPAIN, PORT VILA, PORT-AU-PRINCE, Porto Portugal, PORTO-NOVO, Portsmouth, portugal, Potenza, Powys, Prague, PRAIA, Prato, Preston, PRETORIA, Prince Edward Island, PRISTINA, Pskov, Pune, PYONGYANG, QATAR, Quebec, Quebec City, Queensland, QUITO, Ragusa, Raipur, Rajkot, Ramsey, Ranchi, Ras Abu Aboud, Ras Al Khaimah, Ras Lafan, Ravenna, Rawdat Al Hamama, Rawdat Al Khail, Rawdat Egdaim, Rawdat Rashed, Reading, Redcar and Cleveland, Reggio Calabria, Reggio Emilia, Regina, Relizane, Renfrew, Renfrewshire, Repton, REYKJAVIK, Rhondda Cynon Taf, Rieti, RIGA, Rimini, Rio de Janeiro, Rio Grande, Ripon, Riverside, RIYADH, Romania, Rome, ROSEAU, Rostov, Rotterdam, Rovigo, Rumeilah, Russia, Rutland, RWANDA, Ryazan, Saharanpur, Saïda, SAINT GEORGE'S, SAINT JOHN'S, SAINT KITTS & NEVIS, SAINT LUCIA, Saint Petersburg, SAINT VINCENT & THE GRENADINES, Sakhalin, Salem, Salerno, Salford, Salisbury, Saltash, Samara, SAMOA, SAN JOSE, SAN MARINO, SAN SALVADOR, Sandhurst, SANTIAGO, SANTO DOMINGO, SÃO TOMÉ & PRÍNCIPE, SÃO TOMÉ SAUDI ARABIA, SARAJEVO, Saratov, Saskatchewan, Sassari, Savona, Sawda Natheel, Saxony, Scotland, Scottish Borders, SENEGAL, SEOUL, Separate tags with commas, Serbia, Sétif, Seville, SEYCHELLES, Shagra, Sharjah, Sheffield, Shetland Islands, Shropshire, Sidi bel Abbès, Siena, SIERRA LEONE, Siliguri, Simaisma, singular, Skikda, SKOPJE, Slough, SLOVAKIA, SLOVENIA, Smolensk, Sofia, Solapur, SOLOMON ISLANDS, SOMALIA, Somer, Somer en

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