SOPs vs Batch Records: What Goes Where?
SOPs vs Batch Records: What Goes Where? Clarifying the Roles of SOPs and Batch Records in Pharmaceutical Operations In the pharmaceutical industry, proper documentation ensures consistency, traceability, and compliance. Two key document types—Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs)—play distinct yet interconnected roles. While both are mandated by regulatory bodies like USFDA and…