Pharmaceutical packing operation is a very critical stage of pharmaceutical manufacturing. Following are the guidelines for packing operation.
1. Segregate the products and packing components in the packing area by physical barrier or adequate special separation to minimize mix-ups.
2. Pack and store only one product at a time on any one packing line.
3. Check the product and the respective packing components for conformance with identity and description as per Batch Manufacturing Records (BMR) before commencing operation.
5. Report any discrepancies or irregularities during the packing operation to the production head and quality assurance department.
6. Properly identify all printed, unprinted packing material and bulk products by code no. and lot no. during the process.
7. Destroy the used and unused stereos on completion of a batch/product as per SOP.
8. Destroy the rejected or unused printed packing material on completion of batch/ product and reconcile the same in BMR.
9. For excess packing material, return the same to the warehouse after filling up a return note.
10. Check the BMR for correct completion of all documentation pertaining to the packing, process before submitting it to Quality Control.
11. QA to Check at regular intervals and take random samples to ensure the correction of packing operation.
12. Fill the various logs accurately and regularly to keep a detailed record of packing operation.
13. Pre-inspect the work area & relevant equipment before commencing packing operation.
14. Maintain a strict inventory control and reconciliation of product and respective packing components in each BMR.
1. Segregate the products and packing components in the packing area by physical barrier or adequate special separation to minimize mix-ups.
2. Pack and store only one product at a time on any one packing line.
3. Check the product and the respective packing components for conformance with identity and description as per Batch Manufacturing Records (BMR) before commencing operation.
5. Report any discrepancies or irregularities during the packing operation to the production head and quality assurance department.
6. Properly identify all printed, unprinted packing material and bulk products by code no. and lot no. during the process.
7. Destroy the used and unused stereos on completion of a batch/product as per SOP.
8. Destroy the rejected or unused printed packing material on completion of batch/ product and reconcile the same in BMR.
9. For excess packing material, return the same to the warehouse after filling up a return note.
10. Check the BMR for correct completion of all documentation pertaining to the packing, process before submitting it to Quality Control.
11. QA to Check at regular intervals and take random samples to ensure the correction of packing operation.
12. Fill the various logs accurately and regularly to keep a detailed record of packing operation.
13. Pre-inspect the work area & relevant equipment before commencing packing operation.
14. Maintain a strict inventory control and reconciliation of product and respective packing components in each BMR.
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