TIPS TO MANAGE MENTAL HEALTH
01-SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING (PHARMACEUTICAL)
SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING
1. RESPONSIBILITY AND AUTHORITY:
- Quality Assurance manager
- Quality assurance Officer
- Packing Pharmacist
4. PROCEDURE:
To carry out effective in-process checking control ensures that the following practices are observed by all the packing / in-process control Pharmacist.
· The correct uniform, coats and head-dress must be worn at all times. Gloves and mask also be worn whenever a product is being filled into its primary package and is therefore in danger of contamination during packing.
· In-process check should be carried out on every packing line after every 30minutes especially at the time of start of a new batch or product, on same line in-process check will be carried out.
· Ensure that the packing belt, packing hall, filling machines, conveyor belts and overprinting area is clean and clear.
· Review the line clearance documentation that all the entries are completely filled.
· Check the labels on the containers containing intermediate / finished materials or products to be filled or packed for the product name, strength and batch number. Keep the printed and un-overprinted packing materials clearly segregated.
· Check that the product and material for packing is received on pallet.
· Ensure the physical appearance of the product to be packed matches the description, any changes or discrepancies noted must be escalated to site quality manager /designated.
· Check the overprinting of the aluminum foil strips and embossing on blisters for batch number and expiry.
· Check the area ERH/ Area temperature / ERH of tablets & capsules.(where required)
· Check the area humidity and temperature during filling / packing.
· Leak test must be performed on aluminum foil strips in appropriate manner and every specified intervals.
· Check the aluminum foil strips for open and torn pouches.
· Check the number of strips per pack.
· Check the weight of the powder per bottle on line as per specified fill weight.
· Check the sealing and capping of bottles.
· Check overprinting on strips, bottles, primary pack and fibrates outer label.
· Check that the correct labels used are not damaged, legible and properly aligned.
· All in-process activity / test results / observations must be recorded directly on the batch record. All results must be recorded at the time that the test is performed and must be signed / dated by the person carrying out test.
· Check the outer label quantity, quantity of pack, sign and filler number, sealing of the corrugated boxes and weight of Box.
· Collect retention, stability and commercial samples as per sampling plan/ product specifications and requirement for stability.
· Any discrepancies observed during in-process checking should be immediately be informed to concerned supervisor / officer for rectification and segregation of the specific output for the sorting/ action. Any discrepancies or issues noted must be escalated to the Quality Head / designated for the appropriate action.
· A rejection memo must be issued to production department.
· All in-process test documents must be part of the batch documentation and reviewed prior to batch release.
ALL ABOUT MEDICINE:
5.
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