What belongs in a validation master plan?

Why

EU Annex 15 says the key elements of the site's qualification and validation program should be defined in a validation master plan or an equivalent document. It lists the minimum content: the policy, the organizational structure with roles and responsibilities, a summary of facilities, equipment, systems and processes with their qualification and validation status, change control and deviation management for validation, guidance on developing acceptance criteria, references to existing documents, and the qualification and validation strategy including requalification. Large projects may add separate validation plans for clarity.

The plan's value is that it makes the whole picture visible. An inspector, or a new validation lead, can see which systems are validated, which are overdue for periodic review, and how the site decides how much validation a change needs. Annex 15 also expects risk assessment to drive the scope and extent of validation, and the plan should explain how that is done.

For example, a VMP might state that direct product-contact equipment gets full IQ, OQ and PQ, while indirect equipment gets a reduced set justified by risk. A VMP fails when it is a static document written for a new facility and never updated as equipment, products and processes change, so its status lists no longer match reality.