How to Incorporate Risk-Based Validation Strategy in a VMP: Tools, Levels & Regulatory Expectations How to Incorporate Risk-Based Validation Strategy in a Pharma VMP As validation expectations shift toward science- and risk-based approaches, pharmaceutical companies must update their Validation Master Plan (VMP) to reflect the principles of ICH Q9 and Q10. This article offers a comprehensive, action-focused guide for integrating risk-based validation strategies within your VMP — ensuring both regulatory alignment and operational efficiency. 1. Why Risk-Based Validation Matters The traditional “validate everything equally” approach is no longer sustainable — or expected. Regulatory agencies now encourage validation that’s proportional to…