Any deviation (usually +/- 2%) must be investigated and documented. The Role of BMR in Regulatory Compliance
QA can monitor the batch progress remotely. batch manufacturing record in pharmaceutical industry pdf
Never fill out a BMR at the end of a shift; record data immediately. Any deviation (usually +/- 2%) must be investigated
Use a single line to cross out errors, initial them, and provide a reason for the change. Never use white-out. batch manufacturing record in pharmaceutical industry pdf