SOP for Packing Transfer of Pharma Finished Goods to Bonded Store Room

This SOP explains the simple process for transferring packed pharmaceutical finished goods from the Packing Department to the Bonded Store Room. After packing is completed, the production user records the finished quantity in the SAP system using the completed batch record. The number of shippers or containers is also entered in the inspection lot. Quality Assurance checks the inspection lot, changes its status, withdraws the required sample, and reviews the Daily Production Report. Quarantine status is then applied to the packed goods. The finished goods are transferred to the Bonded Store Room with the required documents. Store personnel verify the received quantity and keep the material under quarantine using a yellow net. After the Batch Packing Record, Quality Control reports, and release documents are reviewed and approved by Quality Assurance, the batch is released. The quarantine status is removed, a passed status is applied, and only released goods are dispatched.

Impact Assessment

This SOP has a positive impact on the safe and controlled transfer of finished pharmaceutical goods from the Packing Department to the Bonded Store Room. It helps ensure that the correct quantity of finished goods is recorded in SAP and matched with the Daily Production Report. QA checking, sample withdrawal, quarantine status, and document review reduce the chance of mistakes or mix-ups. The use of a yellow net clearly identifies goods under quarantine, while a green net and PASSED status show that the batch has been released. Store personnel also verify the received quantity before storage. Final release by Quality Assurance ensures that only approved goods are dispatched. This process improves traceability, proper documentation, stock control, and coordination between Packing, Store, and QA departments. If this procedure is not followed, there may be wrong quantity transfer, incorrect batch status, mix-ups, documentation errors, or dispatch of unreleased finished goods.

Questions & Answers

1. Q: What is the purpose of this SOP?
   A: The purpose is to explain the procedure for transferring packed pharmaceutical finished goods to the Bonded Store Room.
2. Q: Which departments are involved in this process?
   A: Packing Department, Store Department, and Quality Assurance are involved.
3. Q: What should be done after packing is completed?
   A: The production user should enter the finished goods receipt in SAP using the completed Batch Record.
4. Q: What quantity should be entered as goods receipt?
   A: The output quantity should include sample quantity but exclude in-process quantity.
5. Q: What does QA do after checking the inspection lot?
   A: QA changes the inspection lot status from INIT to APGR and withdraws the required sample.
6. Q: What document is printed after sample withdrawal?
   A: The Daily Production Report (DPR) with STO status is printed.
7. Q: How are goods under quarantine identified?
   A: QA places a Quarantine Status Board, and the Store covers the consignment with a yellow net.
8. Q: What does the Store check after receiving finished goods?
   A: The Store checks the received quantity against the DPR quantity and changes the location from PKG1 to FG01.
9. Q: Who reviews the Batch Packing Record?
   A: Quality Assurance reviews the Batch Packing Record and related documents.
10. Q: When can finished goods be dispatched?
    A: Finished goods can be dispatched only after they are released by Quality Assurance. After release, the quarantine board is removed, a PASSED board is placed, and the yellow net is replaced with a green net.