SOP for Finished Product Release | SOP for Approval of Finished Goods in Pharmaceutical Industry
- Approval of Finished Goods SOP covers below points:
- Finished Product Release procedure
- Finished product release checklist
- Finished Product Approval Slip / Finished Product Release format
1.0 OBJECTIVE :
- To describe procedure for approval of finished goods for sell / supply, distribution to trade from FG (Finished Good) Warehouse.
2.0 SCOPE :
- This procedure is applicable to all finished products manufactured at manufacturing site.
3.0 RESPONSIBILITY :
- IPQA Chemist, Quality Assurance Officer, Quality Assurance Head, Quality Control Head, Production Executive, Packing Head and FG Warehouse Officer are responsible for complete implementation of this SOP.
- Q.A. Head
5.0 PROCEDURE :
The basic aim is quality Approved goods leave factory premises.
5.1 Give intimation in form of “Material Transfer Note” to FG (Finished Good) Warehouse by Packing Department after batch completion, reconciliation and BPR completion.
5.2 Physical counting of corrugated boxes and label verification will be carried out by FG Warehouse Officer before transferring the finished goods to FG Warehouse.
- Following checks must also to be done;
- Check Quantity/ Product detail,
- Check Details on the labels or corrugated boxes,
- Check Quantity in loose box
5.3 Keep all Under Test Finished good in quarantine area with batch wise segregation and identification.
5.4 Take entry in ERP system and in daily stock register of Finished Product.
5.5 Quality Control Head has to sign the certificate of analysis (COA) after complete analysis by Quality Control department and after signing the COA shall be issued to packing department.
5.6 Packing person have to attached the COA to Batch Packing Record (BPR) and submit the BPR to Quality Assurance Department.
5.7 Quality Assurance Officer and above has to review and verify the following points before preparing the Finished Product Approval Slip.
- Review respective BMR & BPR.
- Verify that the product have been approved by quality control with respect to its testing as per the product Approved specification and the Certificate of Analysis (COA) is attached with BPR.
- Verify the Quantity being approved and the Quantity transferred to FG Warehouse on “Material transfer note” is same and attached with BPR.
- Verify the Serial No mentioned in “Material transfer note”.
- After review of BMR & BPR. Quality Assurance Officer or above have to make “Finished Product Approved Slip” after verification he/she has to take sign by Quality Assurance Head or Designee on “Finished Product Approved Slip” and issue the first copy to Finished Goods Warehouse and Second copy attached with BPR.
- Make entry of finished product approved intimation in ERP system.
5.8 Shift the finished goods from Quarantine area to approved finished good area and store the goods below 300C till dispatch to trade.
5.9 Keep the completed BMR and BPR under custody of Quality Assurance Head or Designee in Quality Assurance Department after approving.
5.10 Update BMR/BPR Control Register.
|Standard Operating Procedure
|Batch Manufacturing Record
|Batch Packing Record
|Certificate of Analysis
|Finished Product Approval Slip
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
Annex. No. 01 Finished Product Approval Slip