Tag: quality system failure

SOPs Lacking Definition of Critical vs. Non-Critical Deviations: A Hidden GMP Risk

SOPs Lacking Definition of Critical vs. Non-Critical Deviations: A Hidden GMP Risk Missing Clarity in Deviation SOPs: How Undefined Deviation Severity Risks GMP Compliance Introduction to the Audit Finding 1. What’s the Issue? Many GMP facilities have deviation SOPs that don’t clearly differentiate between critical and non-critical deviations. This can delay risk assessment and cause…

Deviation Handling, GMP Audit Findings

Failure to Update SOPs After Emergency Measures: A Persistent GMP Weakness

Failure to Update SOPs After Emergency Measures: A Persistent GMP Weakness Overlooking SOP Revisions After Emergency Measures: A GMP Oversight Introduction to the Audit Finding 1. Emergency Measures Should Not Be Permanent Emergency actions in GMP operations are intended to be short-term responses — not lasting procedures unless properly documented and approved. 2. Risk of…

Emergency Changes, GMP Audit Findings

Undefined Abbreviations and Acronyms in SOPs: A Risk to GMP Documentation Clarity

Undefined Abbreviations and Acronyms in SOPs: A Risk to GMP Documentation Clarity Clarity Risk from Undefined Abbreviations and Acronyms in SOPs Introduction to the Audit Finding 1. Unexplained Terms SOPs often use abbreviations or acronyms like “OOS”, “BMR”, or “CAPA” without defining them. 2. User Confusion Operators and new employees may misinterpret terms, increasing the…

GMP Audit Findings, Poor Writing