risk-based revalidation – Pharma Validation

FDA/EMA Expectations on Change Control & Revalidation: Ensuring Compliance Across the Lifecycle

FDA/EMA Expectations on Change Control & Revalidation: Ensuring Compliance Across the Lifecycle What FDA and EMA Expect from Pharma on Change Control and Revalidation Activities In the pharmaceutical industry, compliance doesn’t end after initial validation. The FDA and EMA both…

Deciding When to Revalidate Using QRM Principles

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,…

Routine, Periodic & Change-Triggered Revalidations in Pharma: What, When & Why Explained

Routine, Periodic & Change-Triggered Revalidations in Pharma: What, When & Why Explained Understanding Routine, Periodic, and Change-Driven Revalidations in Pharma Maintaining the validated state of pharmaceutical processes and systems is a regulatory imperative. Revalidation — whether routine, periodic, or change-triggered…