SOP vs batch record – SOP Guide for Pharma

Unlogged Cleaning Deviations in Batch Records: A GMP Compliance Risk

Unlogged Cleaning Deviations in Batch Records: A GMP Compliance Risk Cleaning Deviations in Batch Records Without Deviation Logging: A Recipe for GMP Trouble Introduction to the Audit Finding 1. Discrepancies in Batch Records Cleaning steps recorded in batch records differ from those described in the approved SOPs. 2. Missing Deviation Reports No deviations were raised…

GMP Audit Findings, Mismatch Between SOPs and Practice

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…

SOP Development, SOP Guidelines