SOP on Line Clearances in Pharma
OBJECTIVE: 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 applies to all activities including dispensing, manufacturing, packaging, and related activities.
Responsibility: The officer/ Executive of the 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 with this SOP
PROCEDURE
Cleaned the equipment and area as per respective SOP.
Affix the ‘CLEANED’ label on each cleaned equipment.
Fill in the area status board.
Before starting any further activity verify the checkpoints mentioned below for giving line clearance by the respective department and IPQA.
If any discrepancy is observed repeat the previous step.
Write the details of the 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.
Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to the previous stage.
Mentioned the Room ID No.
Ensure the absence of batch documents, labels, materials, or any remnants of previous products or batches.
Ensure updation of the status board & ‘CLEANED’ label is affixed on each cleaned equipment. [All equipment shall be clean]
Room conditions such as Temperature, Relative Humidity, and Differential Pressure 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, the area surrounding the equipment, and the area surrounding the balances.
If all the above-mentioned points are found satisfactory, the respective department shall sign the ‘CLEANED’ label.
IPQA department shall sign the ‘CLEANED’ label if the product is approved by Quality Control Department up to the previous stage.
If complies with Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not comply during line clearance.
Line Clearance RLAF:
During the line clearance of any RLAF, the 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 products or batches.
Ensure updation of status board/status label.
Differential Pressure across pre-filters and HEPA filters 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, and Status label on IPC/bin/ balances/dispensing tools.
If all points mentioned above are satisfactory, the respective department shall sign the ‘CLEANED’ label.
IPQA department shall sign the ‘CLEANED’ label if the product is approved by Quality Control Department up to the previous stage.
If complies with Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not comply during line clearance.
Line Clearance Manufacturing Equipment:
During the line clearance of any Manufacturing Equipment following points shall be covered to check and verify.
Mentioned the Equipment ID No.
Ensure the absence of batch documents, labels, materials, powder, tablets, or any remnants of previous products or batches and traces of water surrounding the equipment.
Ensure the absence of batch documents; labels, materials, powder, tablets, or any remnants of previous products or batches and traces of water on each dismantled part of the equipment.
Ensure the absence of materials, powder, tablets, or any remnants of previous products or batches and traces of water on each critical part of the equipment.
Critical & Dismantle parts of all equipment are varying from equipment to equipment. Names of the critical & dismantle parts of all equipment is 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 with Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not comply during line clearance.
If all points mentioned above are satisfactory, the respective department shall sign the ‘CLEANED’ label.
IPQA department shall sign the ‘CLEANED’ label if the product is approved by Quality Control Department up to the previous stage.
Line Clearance Packing Cubical or Line:
During the line clearance of the Packing Cubical or line, the following points shall be covered to check and verify.
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, the 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 products or batches 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
