What is BMR?
BMR (Batch Manufacturing Record) is a comprehensive document that records all details about the batch manufacturing process. This can be information of the raw materials, the equipment used, the process parameters, in-process checks and details about the final product. A BMR is necessary to ensure that all pre-approved instructions and regulatory requirements are followed while manufacturing a batch.
Why is BMR important in pharmaceutical manufacturing?
BMR is integral in the pharma industry to ensure that batches are manufactured following regulatory compliances. BMR ensures prevention of errors by identifying and preventing deviations and increased traceability of the batch manufacturing process. BMR is essential for internal audits and inspections.
What details are recorded in BMR?
A BMR typically records batch identification details, information of raw materials, their quantities, equipment and machinery used, details of the manufacturing process, in-process controls and checks, the environmental conditions, personnel details, the final product specifications and test results.
