SOP for Approval and Release of Finished Product

1.0 OBJECTIVE

To lay down the procedure for release of batch of Finished Product for sale or distribution after ensuring that the product is manufactured, packed and analysed as per the laid down procedures and conforms to the safety, efficacy, purity and quality of the product as per its intended use.

2.0 SCOPE:

This SOP covers the procedure for approval and Release of finished product for sale or distribution from [Company name].

3.0 RESPONSIBILITY:

3.1 Ware house personnel to prepare the Finished product release certificate.

3.2 QA personnel to review the necessary documents (BMR/ BPR/ Analytical data). 

3.3 Head-QA or designee is authorized to release the batch

4.0 PROCEDURE:

4.1 On day to day completion of the packaging of a batch of a finished product, the Packing officer shall send the finished goods to Finished Goods Store with Daily Packing Slip and after final packing send the completed batch records to IPQA.

4.2 Warehouse personnel shall prepare a ‘Finished Product Release Report’ (Annexure-1) and submit it to Head of Quality Assurance or his designee for approval and release of the batch.

4.3 Each Finished Product Release Report shall be identified with specific identification number, which shall be allotted by ware house personnel.

4.4 The ‘Finished Product Release Report’ shall be numbered as FGRXXX/YY. XXX – Serial No., YY – Year.

4.5 After receiving finished product release report from ware house department, QA personnel shall check the following

4.5.1 All the details such as Product name, Batch number, Packaging details, Quantity packed in each type of packing, etc., are duly entered in daily Production slip.

4.5.2 Ensure that BMR/ BPR is complete, reviewed as per Checklist for BMR/ BPR review (Annexure-2) and approved by Quality Assurance.

4.5.3 In case of export pack, refer to the Export Order (EO) and ensure that all requirements of the EO are fulfilled.

4.5.4 Check for any customer specific requirement mentioned in the EO and the amendment letters, if any and ensure compliance to these requirements.

4.5.5 Ensure that the retained sample, pre-shipment sample, sample packing component and stability sample, if applicable, have been withdrawn during packaging.

4.5.6 Ensure that complete analytical reports are received from Quality Control department along with raw data and reviewed by Quality Assurance to ensure compliance to the specifications.

4.5.7 Process Validation batches shall be released only after completion of analysis of all the samples collected during the processing stages as per the validation protocol.

4.5.8 Check and ensure that the batch quantities is tallying with the quantities mentioned in Batch Packing Record (BPR) and in Daily Production slip.

4.5.9 Check and ensure that the containers / shippers are properly sealed.

4.5.10 Check and compare the product details on Daily Production Slip against product details on shippers / containers and ensure that they are same.

4.6 If all the above mentioned points are found satisfactory, QA personnel shall do the reconciliation and sign the ‘Finished Product Release Report’ which will be checked by a QA personnel and than submitted to Head Quality Assurance for approval and release of the batch.

4.7 Head QA or his designee shall ensure the following prior to release of batch.

4.7.1 Manufacturing, packaging and analysis of the batch have been carried out in accordance with the requirement of the cGMP, and  manufacturing license.

4.7.2 Valid manufacturing and testing procedure adopted.

4.7.3 All the necessary checks and tests have been performed and the required documentation of Production and Quality Control have been completed as covered in the Check list.

4.7.4 Any deviation, OOS results, OOT, incidents during manufacturing and analysis of the batch have been handled in accordance with the relevant SOPs and closed before release of the batch for distribution.

4.7.5 Yield calculated phase wise and difference in yield from the specified norms shall be justified.

4.8 Head-QA or his designee shall verify the details of checklist and its compliance and shall release the batch by  signing the “Finished Product Release Report”.

4.9 QA personnel shall take the photocopy of the Finished Product Release Report send one copy to Finished Goods Store for dispatch and preserve the second copy in the BMR/ BPR.

4.10 Reconciliation shall be done at the end of the complete batch dispatch as per the SOP on Yield Reconciliation and then the batch record shall be submitted in Documentation Cell.

4.11 Part release of the batch can be done only after filling Deviation Report with proper justification. Final Reconciliation shall be done at the end.

4.12 In case the batches are meant for bioavailability/ Stability/ Pending license approval/ Site Variation /other purposes, do not send a copy of the Finished Product Release Certificate to Finished Goods Store. The batches shall remain in the quarantine, awaiting approval after the final decision in  concurrence with R&D and Regulatory Affairs.

5.0 ANNEXURES

Annexure I Finished Product Release report

Annexure II Check list for BMR/BPR review

Annexure III Flow chart for release of finished product

Annexure – I FINISHED PRODUCT RELEASE REPORT

Report No.:

Product:         

B. No.:           

Market:           

Batch Size:

Packing Order No. (If any):   

Pack

Sr. No.

Daily Slip No.

Pack Details   

Total Quantity

Batch Reconciliation:

A: Total Qty. Packed (BPR):

B: Qty. Transferred to BSR:

C: Total Qty. Dispatch:

Batch reconciliation =C/B X 100=__________(Limit: 100%)

Done By:                                                        

Checked By:

QA Comments

Remarks: Batch Released / Kept Under Hold

BSR Personnel – Prepared By / Date

Quality Assurance – Checked By / Date

Head Quality Assurance – Released By / Date

Annexure – II QA CHECKLIST FOR REVIEW OF BMR and BPR

QA CHECKLIST FOR REVIEW OF BMR

Product Name:

Batch No.:      

Batch size:

1. BMR is an accurate reproduction of current Master Batch Manufacturing Record (Yes / No)

2. All the issued pages are available (Yes / No)

3.‘Dispensed and Checked’ by columns of BMR against each Raw Material are signed, dated by concerned personnel (Yes / No)

4. Any extra material procured through supplementary material requisition with proper justification (Yes / No)

5. Batch Number mentioned correctly on all pages (Yes / No)

6. Correct manufacturing date and expiry date is assigned (Yes / No)

7. Adjustment of Quantity of Active ingredient as per instructions in batch record (Complete / Incomplete)

8. Issuing of raw materials (Complete/ Incomplete)

9. Weighing Record of raw materials (Complete/ Incomplete)

10. Material details labels (Complete / Incomplete)

11. Area cleaning and clearance record (Complete / Incomplete)

12. Equipment Cleaning and Clearance (Complete / Incomplete)

13. BMR Manufacturing Instructions: All manufacturing instructions followed and accurately documented with respect to identity of equipment used, mixing, drying, loading and blending time durations, etc., with Sign. and Date of personnel performed the activity and checked by Supervisor. (Complete/ Incomplete)

14. Environmental conditions are with in the specified limits (Complete/ Incomplete)

15. In-Process check records during Tablet compression (Complete/ Incomplete)

16. In process check records during coating (Complete/ Incomplete)

17. In process check records during capsule filling (Complete/ Incomplete)

18. Details of sampling performed (Complete/ Incomplete)

19. Phase wise yield reconciliation done (Complete/ Incomplete)

20. If yield is out side the limit is investigated and justified (Complete/ Incomplete)

21. Any deviations / Incidents are appropriately documented, investigated and disposed (Complete / Incomplete)

BMR Review complete/ incomplete

QA (Sign / Date)

QA CHECKLIST FOR REVIEW OF BPR

1. BPR is completed (Yes / No)

2. Yield reconciliation in BPR (Complete / Incomplete)

3. If yield is out side the limit, is investigated and justified (Complete/ Incomplete)

4. All the columns of “Done by and Checked by” are filled in BPR (Complete/ Incomplete)

5. Issuing of packaging material (Complete/ Incomplete)

6. Verification of description and quantity of Packaging material (Complete / Incomplete)

7. Packaging area/ equipment cleaning and clearance (Complete / Incomplete)

8. BPR – Packaging Instructions: All packaging instruction steps filled out referencing equipment used, quantities, Packed, Signed and dated of personnel who perform the activity and checked by Supervisor. (Complete/ Incomplete)

9. Expiry date assigned correctly and mentioned in all packaging records (Complete / Incomplete)

10. Specimen of coded labeling and literature (Complete / Incomplete)

11. In-process checks during packing operation (Complete / Incomplete)

12. Sample collection record (Complete / Incomplete)

13. Labels and packaging material reconciliation record (Complete / Incomplete)

14. Review of Finished product analytical records/other analytical records if any (Complete / Incomplete)

15. Analytical results and yield at every stage is as per the norms (Yes / No)

16. Finished product release report (Complete / Incomplete)

17. Any deviations / incidents are appropriately documented, investigated and disposed (Complete / Incomplete)

BPR Review complete/ incomplete

QA (Sign / Date)        

Annexure – III Flow chart for release of finished product