QMS SOP Template: Deviation Management

Published: July 2025
Pages: 16

• Special Pricing for Emerging Economies

Deviation management is a critical component of the Quality Management System (QMS) and supports compliance with current Good Manufacturing Practices (cGMP) as outlined by regulatory authorities such as 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.

Effective deviation management is essential to ensure product quality, regulatory compliance, and continual improvement across all operations.

This Standard Operating Procedure (SOP) provides a template to help users outline the process for identifying, documenting, evaluating, investigating and resolving deviations from approved procedures, batch records, specifications, or regulatory requirements within a pharmaceutical company’s operations.