In this article we are going to learn about BMR – Batch Manufacturing Record

1.A BMR is a written documentation containing information on how a batch will be manufactured.

2. It Contains Step by step instructions on how a batch will be manufactured.

3. BMR is divided into stages like Dispensing , Granulation, Compression, Coating , Inspection , Packing.

4 .Each stage contains detailed instructions like in granulation the binder preparation procedure , material loading procedure etc

5. BMR contains list of equipment to be used for a particular stage and also list of overall equipment to be used.

6.BMR has provision for recording the list of personal making entries in it

7. A BMR is issued by Quality Assurance department after assigning the batch number , once it is issued it will be reviewed by production.

8.BMR has fixed pages and additional pages can be requested based on the need , in addition to fixed pages it has attachments

Fixed Pages contains

1. Stage wise instructions
2. List of equipment to be used
3. Manufacturing and expiry date
4. List of personal making entries
5. step by step instructions of each process
6. Provision for entry of data
7. Limits of the Process Parameters
8. BOM – Bill of materials

Attachments: These include

1. line clearance activity checklists
2. Equipment cleaning checklists
3. Process Printouts generated during the process.

First Page of BMR –

The first page of BMR contains important information like date of manufacturing, and expiry date of the product, batch size , Batch number , BMR version number, effective or not etc .

The second page of BMR contains specifications and product information.

The Third Page of BMR contains list of personal making entry.

It contains instructions page where how to handle at each stage including the hold time period permitted for each stage .

It Contains a formula Page where standard quantities of the drug and excipients are printed based on that calculation is done in the dispensing page where compensation calculation is done

All Pages of the BMR contains Pg number , batch number , batch size , market of the product etc