Batch Packing Record (BPR)- QA Review Checklist

This article describes about information about batch packing records and QA Review checklist for it. This review shall be done by the Quality Assurance personnel after completion of packing operation.

Batch Packing Record (BPR)- QA Review Checklist

What is Mean by Batch Packing Record (BPR) ?

Batch packing record (BPR) is a document that contains all the essential information about  packing operations and labeling process of a specific batch of a product. It includes details of the packaging materials used, equipment used, and the packaging processes followed and record of the production process.

The BPR is generally prepared based on the information provided in batch manufacturing record (BMR). The BPR provides guide for the packing team to ensure that each batch is packed and labeled consistently and according to the defined standards. This document further can be utilized for Quality Assurance and Regulatory inspection purposes moreover it can be utilized for market complaint and OOS/OOT investigations too. The BPR is usually prepared based on the information provided in the batch manufacturing record (BMR).

Points to be Verified/Review by Quality Assurance Personnel in Batch Packing Record (BPR) before Release of the Batch :

After completion of Packing Operations, Pack sample should be sent to Quality control with the request note containing product name, Batch number. and number of sample and purpose of sample.

EMRM (Excess material return memo) procedure should followed, if any excess material is remined, after packing operations for the specified batch.

on completion of packed sample analysis,  analysis report and Batch packing record should be handover to Quality assurance department for its review.

Quality assurance person should review below points after getting documents for his review :

1. All page numbers have the Product Name and Batch numbers
2. SOP  and Equipment numbers are encircled properly if multiple equipment used for the packing operations.
3. Legible and complete set of BPR
4. No blank spaces should be left in BPR.
5. Authorization of BPR by technical competent employee.
6. All performed Inprocess tests during packing operations are well within the accepted standard.
7. Yields and Reconciliation at each stage are as per the BPR set standards.
8. Packing material request note with report should be reviewed critically for  complete details like material Name, Packing material code, AR number, Grade of the material and product and batch details..
9. All labels like packing material dispensed label, Equipment cleaned label etc. need to review for its correctness.
10. All processing steps including line clearance should be ensured for its sequencings and  correctness respectively.
11. If any deviation logged during packing operations, copy of the deviation should be available with the Batch Manufacturing Record.
12. If any change control logged during batch processing, Change control number should be mentioned on batch packing record.
13. All attachments should be labelled and signed with date.
14. Stereo destruction record should be verified in case of rubber stereo used for overprinting.
15. If any validation performed during packing operations validation batch results summary report should be available with batch packing record.
16. All Utilized equipments for batch manufacturing should be within its calibrated ranges.
17. Preventive maintenance of the utilized equipments performed as per schedule.
18. Details on Rejection analysis.
19. Initial proof check for packing materials and line clearance details should be verified for its correctness
20. Packing material reconciliation should be verified.
21. Correctness of overprinting details against the actual.
22. Production and QA personnel Certified proofs of printed packing material are retained with Batch packing record.
23. Verification of Pack Code ,pharmacopoeial grade with the batch packing record.
24. QC Receipt Packing sample (Testing Sample / Reference sample/Stability sample if any)  should be verified for its correctness.
25. Quality control Release report for packed Tablets should be available with batch packing record.
26. Delivery of batch receipt from packing area to Finished storage area should be verified for its correctness.

Glossary :

BPR : Batch Packing Record

SOP: Standard Operating Procedure