The Line Clearance Procedure is the most important aspect of Pharmaceutical Manufacturing to avoid contamination. To ensure Line Clearance for further production activities, Standard Operating Procedure (SOP) providing below for reference purposes.
Line Clearance SOP
You can review and adopt below LC SOP, subject to the satisfaction of requirements.
SOP Objective
To describe the procedure for line clearance to execute the next product/stage after completion of product/stage change over cleaning as per the cleaning procedure.
SOP Scope
This SOP covers line clearance of products/stages executed after product/stage change over cleaning at the Production block of the Firm.
Responsibility
It is the responsibility of the shift in charge/product in charge to verify and fill the line clearance checklist and Quality Assurance personnel to cross-verify and give clearance to execute the next product/stage.
Line Clearance Procedure
The following points (but not limited to) shall check while giving line clearance.
- Items related to the previous product/stage shall remove from the area. Ensure the below materials’ condition.
- Raw material.
- Packing material.
- Material containers (Intermediates / finished).
- Mother liquors.
- Residues.
- Scoops / scrappers / handling tools/transfer lines/sampling devices.
- Gowning – clean room garments of previous product replaced and sent for washing.
- Filter bags (Centrifuge/leaf filter / Nutsche filter / micronized etc.).
- Filter cartridges (for micro filters).
- Line filters.
- Waste collection bins (in clean rooms).
- Verify adequacy of previous product/stage documentation completion and removal of previous batch documentation:
- Entries in log books.
- Batch production records/packing records.
- Batch cleaning records (equipment).
- Labels.
The process deviations in the previous product/stage shall address as per the Handling of Deviations SOP.
Housekeeping / Area cleaning / Equipment cleaning:
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Assurance of Satisfactory Line Clearance
Ensure correct cleaning procedures are available.
To ensure the results are passing as per specifications (Acceptance criteria).
Check visually and ensure that equipment is clean and dry. Ensure that the critical areas of equipment (such as the inner top dish, anchor bolts, and baffles) are clean.
Check visually and ensure that the area is clean and dry.
Ensure hosepipes, pipelines, centrifuge MLs pit, samplers, scrappers, handling tools and scoops are clean and dry.
Special Care for Clean Room Assurance
Only one product shall be processed at a time in a clean room.
Air pressure within the range.
Controlling the temperature and relative humidity to the desired limits.
Cleaning/changing of air filters.
Cleaning of exhaust and inlet clean air grills.
Ensure no accumulations on the floor, walls, and utility lines outer surfaces of the equipment, windows, and doors.
Ensure the following things related to equipment:
Cleaning/changing of process filters.
Condition of gaskets.
Missing nuts and bolts.
Important Notes
Operators as per the authorized list. If not, check the training record and get the list amended.
Issue of correct Batch production records for next product/stage execution.
Calibration of balance(s).
Approval of input materials.
Tallying of batch numbers/quantities mentioned on material release slip and raw material requisition.
The shift/product in charge shall verify all the points mentioned in 6.1. Fill out the line clearance checklist and forward it to Quality Assurance for getting the clearance.
Upon receipt of the line clearance checklist from the production, Quality Assurance personnel shall go and cross-check documents, area & equipment.
Based on the cross-checking of documents, area, and equipment, Quality Assurance personnel shall decide and give the clearance for starting the next product/stage batch. If any abnormalities are found, inform to shift / product in charge and get them rectified.
Sign the line clearance checklist and file it in the Quality Assurance department.
Note 1. Line clearance checklist is applicable for API (Crystallizer, Powder Processing activity).
2. For Intermediate stages clearance shall give after product change over-cleaning. (QA Executive shall evaluate product changeover ECR).