Guide to the Packing Process For Pharmaceutical Companies
The packing process is an integral part of the manufacturing process for pharmaceutical products. Below is a summary of good practices that may help streamline the packing process.
- Physically separate the finished products and the packing materials in the packaging area to avoid any mix-up of finished and unfinished items.
- Prevent mix-ups by packing one type of product at a time.
- Before starting the packing process, check the product and the packaging to make sure that these conform to the descriptions given in the batch manufacturing record (BMR) of the product.
- Remove rejects or discard any products that are not included in the batch.
- Report any problems including discrepancies during the operation to the QA department and to the head of production.
- Identify the packing materials used during the process with the code and lot number as per the BMR.
- Destroy any excess used or unused packing materials as per standard operating procedure (SOP).
- Destroy any unprinted or printed unused packing materials after the process is complete, and reconcile these with the BMR.
- For excess materials, return these back to the warehouse and file a return note.
- Check the BMR to make sure that all documents are in order before submitting to the QA department.
- QA should regularly check and do random testing to make sure that packing procedures are correctly followed.
- Keep a detailed record of the packing operation, and keep it up to date every time there is a packing operation or change of procedure.
- Inspect the packing area and the equipment before starting the packing operation.
- Maintain a strict inventory and reconciliation of the products in respect to its packing components as indicated in the BMR.