OOS - Out of Specification Results


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.

This SOP Template is in comliance with FDA 21 CFR 211.165, 21 CFR 211.160, 21 CFR 211.192 and the EU GMP Guide Part 1, 1.4 (vii)

The FDA Guideline “Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production was considered.

This is one example page:

sop example oos out of specification results

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

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