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 Record (BMR) before commencing
operation.
4. Check all rejected
excess or discarded printed packing material with respect to work order.
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. Q.A. 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 pacing
operation.
13. Pre-inspect
the work area & relevant equipment before commencing pacing operation.
14. Maintain a
strict inventory control and reconciliation of product and respective packing
components in each BMR.
