The purpose of this Standard Operation Procedure is to establish and describe the principle steps involved for the handling of out-of-specification (OOS) laboratory results. The investigation or ‘failure investigation’ should identify the cause or root cause of the OOS and evaluate its impact on the tested product.
The FDA Guideline “Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production was considered.
This is one example page:
The procedure is applicable to all GMP testing laboratories testing e.g. excipients, raw materials, water analysis, utilities, environmental conditions, packaging materials and components, drug substance, finished drug product, device components, finished devices and any stability samples.
Copyright 2011 by Standard Operating Procedure