PHARMACEUTICAL DOCUMENT LIBRARY · VMP
A Validation Master Plan defines how a site organises and controls its qualification and validation programme. Use this section to explore the planning framework and related published SOPs.
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Validation Master Plan
Editable Validation Master Plan (VMP) template for pharmaceutical API facilities, covering qualification, process and cleaning validation, analytical methods and computerized systems. Includes 14 annexures for equipment lists, validation planning, calibration and preventive maintenance.
39 pages · DOCX
View document detailsEU GMP Annex 15 describes a validation master plan or equivalent document as the place to define the key elements of the site’s qualification and validation programme. Its scope should reflect the facilities, systems, equipment and processes involved.
Define the purpose, boundaries and overall qualification and validation approach.
Identify ownership, technical responsibilities, review and quality oversight.
Summarise the relevant facilities, equipment, utilities, systems and processes.
Explain the qualification and validation strategy and how acceptance criteria are developed.
Reference the supporting procedures, plans, protocols and reports.
Describe the controls for changes, deviations and continued maintenance of the validated state.
For validation, engineering and QA teams coordinating a site qualification and validation programme.
Check the planning scope and document structure against your site. Confirm which supporting protocols or records are included in the published package.
Use the SOP to define preparation and maintenance responsibilities. The completed plan should describe the site-specific programme.
Validation Master Plan (VMP) is the term used in EU GMP Annex 15 for the site-level qualification and validation planning document, or its equivalent.
The VMP establishes the overall framework. Individual protocols and reports provide the study-specific methods, acceptance criteria, results and conclusions.
Some users search for Validation Master File when looking for a master validation document. This section uses Validation Master Plan (VMP), the term in the linked Annex 15 reference; confirm your organisation’s document title and scope.