1.0 Objective: – To lay down the procedure for in-process checks during liquid oral manufacturing and packing.
2.0 Scope: – This procedure is applicable for in process checks during liquid oral manufacturing and packing.
Executives QA shall be responsible for preparation and execution of the procedure
Manager QA shall be responsible for checking and compliance of the SOP.
4.0 Accountability: – Head QA shall be accountable for compliance of the SOP.
- Check, purified water to be use in batch manufacturing shall be QC approved before starting the bulk manufacturing.
- Line clearance of the bulk manufacturing area, equipment and process shall be given
- On receipt of test request form from production, collect the bulk sample for QC analysis.
- Verification of the yield shall be done at the end of bulk manufacturing stage.
5.2 Air Jet Cleaning
- Line clearance of the air jet cleaning area, equipment and process shall be given.
- Check the pressure of air jet cleaning machine, it should be with in limit of BMR.
- Check the bottle for cleanliness.
5.3 Filling and Sealing Operation
- Line clearance of the filling & sealing area, equipment and process shall be given.
- On completion of initial setting of filling machine check the filled bottle for In process parameter.
- Bottle shall be taken from each filling nozzle for In process checks.
- If parameter of filled bottles is with in specified limits of BMR, further operation of the filling machine shall be allowed otherwise the setting shall be rectified accordingly.
- IPQA executive shall perform the In process checks at a 4 hours frequency after the line clearance has been given or whenever there is a break down or machine is stopped for then 1 hour.
- Bottle taken for In process checks shall be treated as “Non recoverable”.
- Following In process checks shall be performed and recorded in “In-process checks for Liquid oral”.
- Filled Volume
- Cleanliness of container
- Sealing quality
- Dented / scratch mark / stained / cracked bottle
- If, during In process checks, it is found that any parameter of filled bottle is out of the specified limits, as per BMR, the machine shall be stopped.
- The bottles filled between the last check (by production or QA which ever is latest) and current check shall be segregated.
- All the bottles shall be checked for compliance (of In process parameter) to the specifications as per the BMR.
- The bottles, which are out of specified limit, shall be labeled, as “On Hold” and rest of the bottles shall be cleared if all parameter are with in specified limits of BMR.
- Manager QA shall take the decision on “On Hold” bottles.
5.4 Labeling and packing operation
- Line clearance of the labeling & packing area, equipment and process shall be given.
- Verify the coded Label & packing material for details like Batch No., Mfg. Date, Expiry Date, MRP and manufacturing Lic. No. etc. as per BMR.
- Perform the In process checks at a 4 hours frequency after the line clearance has been given.
- Following In process checks shall be performed and recorded in “In-process checks for Liquid external – packing”
- Cleanliness of container / Label
- Text matter on label / Container
- Coding detail on label and container
- Quality of gumming / missing of label / Cross labeling
- Number of containers in shipper and there packing arrangement
- Coding detail on shipper
- BOPP taping quality
- Collect the packed finished sample, control samples and stability samples or any other required samples during packaging operation.
- Verify the yield reconciliation after the completion of packing.