Mandates comprehensive documentation of every significant step, equipment cleaning logs, and dual sign-offs for critical tasks.
A comprehensive BMR, often exceeding dozens of pages, must include specific information. According to ICH Q7 (GMP for Active Pharmaceutical Ingredients) and 21 CFR Part 211 (US FDA), a typical BMR contains the following sections:
: Product name, unique batch number, and manufacturing/expiry dates. Bill of Materials (BOM)