- A batch Manufacturing Record, also known sometimes as the Batch Production Record, is an approved copy of the MFR for each batch of product being processed, in which data has been filled in during the batch processing. It contains details of the location where production is done, data entries, names of operators making the entries and their signatures with dates, supporting data records (such as cleaning records, equipment calibration details, in-process, and final quality control test reports, etc).
- The Batch Manufacturing Record details the unique batch number assigned to that particular batch. This information must be recorded in a logbook along with the date on which the batch number is allotted, the identity of the product, and the batch size.
Contents of Batch Manufacturing Record
- Name of the product.
- Date and time of commencement and completion of important stages in the processing.
- Name of persons responsible for each critical stage, with initials of operators handling each operation and persons who checked these operations.
- Name and quantities of each raw material weighed with the batch number from which the material was drawn (including details of any re-processed materials added).
- Major equipment used in the processing.
- Results of readings for critical processing parameters.
- Details of samples drawn.
- In-process testing reports.
- The actual yield was obtained at critical phases.
- Any deviations from the procedure, with signatures to authorize the deviations; their evaluation and investigation is conducted.
- Packaging material and label description, with representative material attached.
- Results and reports of Quality Control Testing of the final product for batch approval.
- Statement about the decision taken regarding approval or rejection of the batch along with the date, and name, and signature of the person making this decision.
- A batch manufacturing record is a written document of the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and the whole manufacturing process step by step.
- There are several stages of the pharmaceutical tablet manufacturing process. All stages are included in the batch manufacturing record from the issuance of the raw material to the final packaging. Every batch has a separate BMR having the batch history of batch production. Documents and proofs are attached in the BMR during the manufacturing process.
A good Batch Manufacturing Record format should contain the following parts:
Batch Record:
- The very first page of the BMR has all records about the batch as batch number, batch size, composition, master formula record referred, the weight of the batch, shelf life, storage conditions, manufacturing license number, manufacturing date, expiry date, date of starting and date of completion.
General Instruction for Manufacturing:
- Health and safety instructions to the operators and the manufacturing chemist are written those should be followed during the manufacturing process regarding the material and equipment used during manufacturing.
Equipment Cleaning Record:
- A checklist of the cleaning of all equipment is prepared; those are used in the manufacturing of the batch including the previous product, batch and date of cleaning. Cleaning of the equipment should be checked by quality assurance.
Bill of Materials:
- A list of the raw material should have the quantity of the materials with their AR numbers. The weights of the materials should be verified by quality assurance. If tablets are coated then coating material should be included.
Manufacturing Process:
- The manufacturing process should be written step by step in easy language. Milling, sifting, drying, lubrication, compression, coating, and packing all instructions with process time should be written. A checklist for line clearance should also be attached before starting every process.
- After completion of every stage, tablets must be checked for compliance of the specification of that stage. Results should be attached to the batch manufacturing record.
Yield:
- The yield of the batch should be calculated at the end of every stage to calculate the process loss. The final yield should be calculated at the end of the manufacturing that should not be less than 99.00%.
Abbreviations:
- A list of the abbreviations used in the document should be made to understand the BMR easily.
History of Chances:
- At the end, the document should have a list of the changes in the document including the revision number and the date of the change.
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