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A batch manufacturing record is a written document from the batch that is prepared during the pharmaceutical manufacturing process. It contains step-by-step batch production and actual information of the entire production process.
There are several steps in the pharmaceutical product manufacturing process. All stages from raw material issuance to final packaging are included in batch production records.
Each batch has a separate BMR with a batch history of batch production. Documents and evidence are attached to the BMR during the manufacturing process.
A good batch manufacturing record format should contain the following parts:
1. Batch Record: The first page of BMR contains all the records about the batch such as batch number, batch size, composition, master formula record batch weight, shelf life, storage conditions, manufacturing license number, manufacturing date, expiry date, start date and Completion Date
2. General Instructions for Manufacturing: Operators and manufacturing chemists have written health and safety instructions that should be followed during the manufacturing process regarding the materials and equipment used during manufacturing.
3. Equipment cleaning records: All equipment cleaning checklists are prepared; They are used in the production of batches with previous product, batch and cleaning dates. Equipment should be cleaned by quality assurance.
4. Bill of Materials: The list of raw materials should contain the quantities of materials with their AR numbers. Weight of materials should be verified by quality assurance. Coating material should be included if tablets are coated.
5. Manufacturing process: Manufacturing process should be written step by step in simple language. All instructions should be written including the timing of milling, sifting, drying, lubrication, compression, coating and packing process. Checklist for line clearance should also be attached before starting each process.
After each stage is completed, tablets must be tested for compliance with that stage’s specifications. The results should be attached to the batch production record.
6. Yield: Batch yield should be calculated at the end of each stage to calculate process loss. The final yield should be calculated at the end of production which should not be less than 99.00%.
7. Abbreviations: Abbreviations used in the document should be listed so that BMR can be easily understood.
8. Prospective history: At the end, the document should contain a list of document changes with revision number and date of change
