What a validation master plan should contain
The VMP is the site-level statement of validation policy, scope, responsibilities and schedule. It tells an inspector how the organisation decides what to validate and how.
Annex 15 requires the key elements of the qualification and validation programme to be defined and documented in a validation master plan or equivalent. The VMP is not a protocol; it is the policy and inventory from which protocols follow.
Typical contents
- Validation policy and the quality risk-management approach.
- Organisational structure, roles and responsibilities.
- Summary of facilities, equipment, systems and processes with their validation status.
- Documentation formats: protocol and report templates, acceptance-criteria conventions.
- Change control and deviation management as they apply to validated state.
- Schedule and prioritisation.
- Reference to existing documents and to periodic review and requalification.
A VMP that lists every storage area with its mapping status and next review date is one of the simplest ways to show control of environmental qualification.
Frequently asked questions
- Does a GDP wholesaler need a VMP?
- The term comes from GMP, but a documented qualification approach and inventory serves the same purpose and is expected by inspectors.
References
- [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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