Defining Scope in a VMP: What to Include & Exclude for Regulatory Clarity Defining Scope in a Pharma VMP: What to Include & Exclude for Regulatory Clarity The Validation Master Plan (VMP) is a cornerstone document in pharmaceutical quality systems. It defines the approach, strategy, and schedule of validation activities. A critical element of the VMP — often scrutinized during audits — is the definition of its scope and boundaries. Clearly delineating what is included and excluded from validation, and why, ensures the VMP is not only compliant but also practical and risk-based. This article provides a comprehensive guide to…