Batch Manufacturing Record (BMR)

Batch Manufacturing Record (BMR) also known sometimes as the Batch Production Record, this is an approved copy of the MFR for each batch of product being processed, in which data has been filled in during processing of the batch. 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 BMR bears details of the unique batch number assigned to that particular batch. This information must be recorded in a log book along with the date on which batch number is allotted, the identity of the product, and the batch size.

Contents of BMR

• 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 actually 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.

• Actual yield 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 QC testing of the final product for approval of the batch.

• Statement about the decision taken regarding approval or rejection of the batch along with the date, name, and signature of the person making this decision.

Data Recording in Logbooks

• Logbooks must be maintained for critical production equipment, analytical instruments, and for environmental conditions in areas where processing takes place.

• Entries must be made in chronological order, with dates, at the time of the activity; pre-completion of entries is prohibited.

• The person who performed the operation must be identified.

• Only trained and authorized persons must do the data entry in the logbooks.

• Data recorded must reflect actual display on the equipment panels (for example: with all decimals, no rounding off unless pre-defined and documented instructions exist for this).

• Any unusual observations must also be recorded with date and signature and immediately reported to personnel in charge of that area as well as the QA department.

• Data that is repeated must be written again; putting –”- marks, or –do – or “Ditto” or “same as above” is not acceptable.