QMS SOP Template: Investigations

Published: July 2025
Pages: 14

• Special Pricing for Emerging Economies

Effective investigation processes are essential to identify root causes, assess product impact, implement corrective and preventive actions (CAPA), and ensure ongoing compliance with current Good Manufacturing Practices (cGMP) as required by global regulatory authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

This Standard Operating Procedure (SOP) includes a template to help the user outline the systematic approach to conducting investigations related to deviations, non-conformances, Out-of-Specification (OOS) results, product complaints, and other quality-related events within a pharmaceutical company’s operations.