Pharmaceutical Packaging as per GMP Guideline

By: Pharma Tips | Views: 5203 | Date: 15-May-2015

Learn about the critical process of pharmaceutical packaging.

Pharmaceutical Packaging as per GMP Guideline

Learn about the critical process of pharmaceutical packaging.


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.

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