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PLANREFERENCE OUTLINE
Validation Master Plan (VMP) Shell
Site-level VMP structure covering validation strategy, scope, organization, and scheduling. Pre-populated with 21 CFR 211 and Annex 15 alignment sections.
REGULATIONS MAPPED
21 CFR Part 211EU GMP Annex 15
DOCUMENT TYPE
PlanLAST UPDATED
July 2024PURPOSE
A site validation master plan structure defining validation strategy, scope, organisation, and scheduling, pre-aligned to 21 CFR 211 and EU GMP Annex 15.
What's Inside
✓Validation policy and scope
✓Organisational responsibilities
✓Facility / equipment / process / CSV inventory
✓Risk-based validation approach
✓Revalidation triggers and schedule
How to Use It
1State the site validation policy and governing standards
2Inventory the systems requiring validation
3Assign responsibilities across functions
4Define the risk-based approach and lifecycle model
5Publish the schedule and revalidation triggers
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Validation Policy and Governing Standards
2Scope and Objectives
3Organisational Roles and Responsibilities
4Facility / Equipment / Process / CSV Inventory
5Risk-Based Validation Approach and Lifecycle Model
6Deliverables and Documentation Structure
7Revalidation Triggers and Periodic Review
8Validation Schedule and Matrix
REGULATORY CONTEXT
EU GMP Annex 15 and 21 CFR Part 211 expect a documented, risk-based validation program. The VMP is the governing document inspectors ask for first.