Deciding When to Revalidate Using QRM Principles How to Decide When to Revalidate Using Quality Risk Management (QRM) Principles Revalidation in the pharmaceutical industry is essential for maintaining a consistent, GMP-compliant, and validated state of processes, systems, and equipment. However, revalidating too frequently can drain resources, while under-revalidating can lead to non-compliance. Quality Risk Management (QRM) principles — particularly those described in ICH Q9 — offer a structured approach to strike the right balance. This article explains how to apply QRM to determine when revalidation is necessary. It covers risk tools, regulatory expectations, and integration with the overall validation lifecycle….