Revalidation Protocols, Reports & Justifications How to Document Revalidation in Pharma: Protocols, Reports & Justifications Explained In pharmaceutical validation, robust documentation is not just good practice — it’s a regulatory obligation. Whether you are performing revalidation due to a process change, periodic schedule, or risk-based decision, the entire activity must be thoroughly documented. This includes the revalidation protocol, execution records, raw data, summary reports, and most critically, the justification for the approach taken. This guide details how to effectively write, manage, and archive revalidation documentation in compliance with FDA, EMA, and ICH requirements. Whether you’re a QA reviewer or a…