Is the VMP required by regulation?
Yes, the VMP is required by GAMP 5, EU GMP Annex 15, and FDA guidance.
Validation Master Plan (VMP)
Validation Master Plan (VMP) authoring for pharmaceutical manufacturers. The VMP is the top-level document that defines the validation strategy, the GxP systems inventory, the validation governance, and the lifecycle management approach.
GxP systems inventory
The VMP includes the GxP systems inventory: the list of GxP-impact systems, their GAMP 5 categorization, their current validation state, and the validation lifecycle stage.
Validation strategy
The VMP defines the validation strategy per GAMP 5 category, per risk level, and per system complexity.
Validation governance
The VMP defines the validation governance: the roles, the responsibilities, the decision rights, and the escalation paths.
Validation lifecycle management
The VMP defines the validation lifecycle management: the validation at go-live, the change control during operations, the periodic review schedule, and the retirement process.
How to use this page
Use this Validation Master Plan (VMP) page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For Validation Master Plan (VMP), prepare the records, owners, risks and decision criteria linked to gxp systems inventory, validation strategy, validation governance, validation lifecycle management. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
How long does VMP authoring take?
For a typical site with 20-50 GxP systems, VMP authoring takes 4-8 weeks.