QMS SOP Template: Out-of-Specification

Published: July 2025
Pages: 14

• Special Pricing for Emerging Economies

This Standard Operating Procedure (SOP) template provides a structured approach for the identification, investigation, evaluation, and resolution of Out-of-Specification (OOS) results observed during pharmaceutical manufacturing and testing. The objective is to ensure that all OOS results, whether from in-process testing, finished product testing, raw materials, or in-process samples, are addressed in a scientifically sound, compliant, and timely manner while upholding regulatory requirements and promoting product quality and patient safety.