Batch Manufacturing Record (BMR) – QA Review Checklist 1

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

Batch Manufacturing Record (BMR) – QA Review Checklist

What is mean by Batch Manufacturing Record?

Batch manufacturing record (BMR) is a document or set of documents that contains all essential information about the manufacturing process of a specific batch of a product. It includes details of Raw Materials used, equipment utilized, and manufacturing processes followed and record of the production process.

The BMR provides information about batch processing instructions as a guide for production team to ensure that each batch is produced 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.

Points to be verified/Review by Quality Assurance Personnel in Batch Manufacturing Record :

After completion of Batch Manufacturing, Bulk sample should be sent to Quality control for testing with the request note containing product name, Batch number. and number of sample.

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

Quality assurance person should review below points once he received records for review :

1. All page numbers have the Product Name and Batch numbers
2. SOP numbers and Equipment numbers are encircled properly if multiple equipment used for the processing.
3. Legible and complete set of BMR
4. No blank spaces should be left in BMR.
5. Authorization of BMR by technical competent employee.
6. All performed Inprocess tests during manufacturing are well within the accepted standard.
7. Yields and Reconciliation at each stage are as per the BMR set standards.
8. Raw material request note with report should be reviewed critically for  complete details like material Name, Raw material  code, AR number, Grade of the material and product and batch details..
9. All labels like Raw material dispensed label, Equipment cleaned label, Inprocess 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 batch processing, 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 manufacturing record for further tracking if any.
13. All attachments should be labelled and signed with date.
14. If any validation performed during this batch validation batch results summary report should be available with batch manufacturing record.
15. Quality control Release report should be available with batch manufacturing record.
16. Utilized purified water report should be available in batch manufacturing record.
17. Environmental monitoring test results should meet as per requirements.
18. All Utilized equipments for batch manufacturing should be within its calibrated ranges.
19. Preventive maintenance of the utilized equipments performed as per schedule.

Glossary :

BMR : Batch Manufacturing Record

QA : Quality Assurance

SOP : Standard Operating procedure

OOS : Out of specification

OOT : Out of Trend

AR Number : Analytical Report Number