SOP on Line Clearances

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

SCOPE:The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities.
Responsibility: Officer/ Executive of respective department and IPQA shall be responsible to follow the procedure mentioned in this SOP.
ACCOUNTABILITY: Department Head and Quality Assurance Head shall be accountable for compliance of this SOP

Abbreviations and Definitions
IPQA: in – process quality Assurance

Metformin Hydrochloride Tablet 500 mg (drugsformulations.com)

PROCEDURE
- Cleaned the equipment and area as per respective SOP.
- Affix ‘CLEANED’ label on each cleaned equipment.
- Fill the area status board.
- Before starting any further activity verify the checkpoints mentioned in the annexure no. 01, for giving line clearance by respective department and IPQA.
- If any discrepancy is observed repeat the previous step.
- Write the details of previous product and next product [Name & Batch No.] at each different area.
- Line Clearance Manufacturing Area:
- During the line clearance of any Manufacturing Area following points shall be covered to check and verify in annexure no. 01.
- Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to previous stage.
- Mentioned the Room ID No.
- Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
- Ensure updation of status board & ‘CLEANED’ label is affixed on each cleaned equipment. [All equipment shall be clean]
- Room conditions as Temperature, Relative Humidity and Differential Pressure are must be within limits.
- Area status board for cleanliness shall include the clean status of return air raisers, supply air raisers, floor, ceiling, walls, drainage, light fixtures, dustbins, Containers, Tools, Vacuum cleaner, area surrounding the equipment and area surrounding the balances.
- If all above mentioned points are found satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- Line Clearance RLAF:
- During the line clearance of any RLAF following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Room ID No.
- Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
- Ensure updation of status board/status label.
- Differential Pressure across pre-filters and HEPA filters are must be within limits.
- Ensure cleanliness of Area, Cleanliness of Balances, Calibration of Balances, Cleanliness of Supply Air Grills of RLAF unit, Cleanliness of Return Air Grills of RLAF unit, Status label on IPC/bin/ balances/dispensing tools.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- Line Clearance Manufacturing Equipment:
- During the line clearance of any Manufacturing Equipment following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Equipment ID No.
- Ensure the absence of batch documents, labels, materials, powder, tablets or any remnants of previous product or batch and traces of water surrounding the equipment.
- Ensure the absence of batch documents; labels, materials, powder, tablets or any remnants of previous product or batch and traces of water on each dismantle part of the equipment.
- Ensure the absence of materials, powder, tablets or any remnants of previous product or batch and traces of water on each critical part of the equipment.
- Critical & Dismantle parts of all equipment are varying from equipment to equipment. Name of the critical & dismantle parts of all equipment are mentioned individually in the line clearance checklist Annexure no. 01.
- Weighing balances and Analytical balances of each area shall be cleaned and calibrated as per their frequency.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- Line Clearance Packing Cubical or Line:
- During the line clearance of Packing Cubical or line following points shall be covered to check and verify in annexure no. 01.
- Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to previous stage.
- Mentioned the Room ID No./ Line No.
- Ensure the absence of batch documents, labels, materials [Primary/Secondary/Tertiary packing materials] or any remnants of previous product or batch.
- Ensure updation of status board & ‘CLEANED’ label is affixed on each cleaned equipment.
- Room conditions as Temperature, Relative Humidity and Differential Pressure are must be within limits.
- Area status board for cleanliness shall include the clean status of return air raisers, supply air raisers, floor, ceiling, walls, drainage, light fixtures, dustbins, Containers, Tools, Vacuum cleaner, area surrounding the equipment.
- Ensure that the absence of tablets, strips, blisters, plain aluminum foil, printed aluminum foil, PVC foil, PVDC foil of previous batch or product and oil/water leakages.
- Above mentioned materials may be excess remaining or rejected during machine setting or on line rejected.
- Ensure that the absence of the recoverable/rejected/defoiled strips, blisters or tablets.
- Ensure that the overprinting stereos of previous product or batch are destroyed.
- Batch Manufacturing Record of current batch, which is to be started, shall be completed up to production head sign and reviewed by IPQA.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- Line Clearance Packing Equipment:
- During the line clearance of Packing Equipment following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Equipment ID No.
- Ensure the absence of batch documents, labels, materials, powder, tablets or any remnants of previous product or batch and traces of water surrounding the equipment.
- Ensure the absence of batch documents; labels, materials, powder, tablets, strips, blisters or any remnants of previous product or batch and traces of oil/water on each dismantle part or surrounding the equipment.
- Ensure the absence of materials, powder, tablets or any remnants of previous product or batch and traces of water on each critical part of the equipment.
- Critical & Dismantle parts of all equipment are varying from equipment to equipment. Name of the critical & dismantle parts of all equipment are mentioned individually in the line clearance checklist Annexure no. 01.
- Recoverable, Rejected or defoiled strips/blisters/tablets of previous batch or product must be removed.
- Weighing balances and Analytical balances of each area shall be cleaned and calibrated as per their frequency.
- If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
- If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
- IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
- Entry of primary, secondary & tertiary packing materials can be acceptable.
- Machine setting and removal of proof shall be accepted. Production department shall sign proof, but machine could not run before getting line clearance from IPQA.
- IPQA shall verify the proofs and can give final line clearance to start the batch packing only after getting the result of previous stage from quality control department.
- In case if manual coding is to be carried out, for cartons and / or labels, following points shall be covered to check and verify in annexure no. 01.
- Mentioned the Room ID No.
- Ensure the absence of batch documents, labels, materials [Primary/Secondary/Tertiary packing materials] or any remnants of different product or batch.
- Ensure updation of status board or ‘CLEANED’ label is affixed.
- Area status board or affixed ‘CLEANED’ label for cleanliness shall include the clean status of floor, ceiling, walls, light fixtures, dustbins, Cage and surrounding area.
- Ensure that the absence of printed, overprinted cartons of any different batch or product.
- Ensure that the overprinting stereos of previous product or batch are destroyed.

- Forms and Records.
- Line Clearance Checklist of Area and Equipment for Manufacturing and related Area- Annexure -I
- Distribution
  - Master Copy- Documentation Cell (QA)
  - Controlled Copies-Production and Quality Assurance
- History

Date

Revision

Number

Reason for revision

–

New SOP

MASTER FORMULA OF PHENYLEPHERINE HYDROCHLORIDE,CETRAZINE DIHYDROCHLORIDE ,ARACETAMOL & CAFFEINE ANHYDROUS TABLETS (drugsformulations.com)

A 9 -

A 7 -

A 8 -

Annexure-I

Line Clearance Checklist of Area and Equipment for Manufacturing and related Area

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.

Stage areas / room & equipment	Checks		Checked By	Verified By
Stage areas / room & equipment	Checks		Production	QA
Vacuum cleaner	Equipment ID No.: ____________________ Ensure the absence of batch documents, labels, powder, materials or remnants of previous product or batch. Area surrounding the Equipment
	ENSURE THE 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.

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

Stage areas / room & equipment	Checks		Checked By	Verified By
			Production	QA
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]
	ENSURE THE 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]
	ENSURE THE CLEANLINESS OF
	Floor Walls Ceiling Drain Supply air Grills Return air Grills Light Fixtures Waste Bins Container Tools Vacuum cleaner	Area below the vibro Sifter. Area below the sifter cum multimill. Area below the FBD/FBP. Area below the RMG Area below Tippler Area below OGB Area below Multi mill Area below oscillating Granulator

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

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.

*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

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.

*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

*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.

*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 q 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.

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.

Clotrimazole Tablet (drugsformulations.com)

SOP on Line Clearances

Metformin Hydrochloride Tablet 500 mg (drugsformulations.com)

MASTER FORMULA OF PHENYLEPHERINE HYDROCHLORIDE,CETRAZINE DIHYDROCHLORIDE ,ARACETAMOL & CAFFEINE ANHYDROUS TABLETS (drugsformulations.com)

Clotrimazole Tablet (drugsformulations.com)

Pharma More Jobs and post Please click here

Do Not Sell My Personal Information