A for a specific dosage form (tablets, liquids, etc.) A checklist for QA BMR review Guidance on Data Integrity requirements for documentation
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
Any deviation (usually +/- 2%) must be investigated and documented. The Role of BMR in Regulatory Compliance A for a specific dosage form (tablets, liquids, etc