Validation Master Plan (VMP)

The Validation Master Plan (VMP) is a high-level document within a pharmaceutical company's quality system that outlines various aspects related to the execution of validation activities, as well as often associated tasks (e.g., sensor calibration). Specifically, it describes the policy, responsible personnel, types of activities conducted, systems subject to qualification, processes subject to validation, documentation formats, validation schedules, and so forth.

The Validation Master Plan (VMP) can be comprehensive, covering all production sites and projects within the company. Alternatively, separate Validation Master Plans may be developed for each specific production site or project within the enterprise.

The results of the preliminary risk assessment (basic risk analysis) serve as input for the section of the VMP known as the Qualification/Validation Matrix. The Qualification/Validation Matrix is a table that defines which validation stages should be conducted for which systems and processes.

The Validation Master Plan should be developed as early as possible in the manufacturing facility design phase. The initial version of the VMP can be drafted even before the basic risk analysis is conducted, but the completion of one of the most critical sections of the VMP – the Qualification/Validation Matrix – is only possible after the basic risk analysis has been performed.

EU GMP Guidelines Annex 15: Qualification and Validation provides the following definition of the VMP:

“…1.4. The key elements of the site qualification and validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent document.

1.5. The VMP or equivalent document should define the qualification/validation system and include or reference information on at least the following:

i. Qualification and Validation policy;

ii. The organisational structure including roles and responsibilities for qualification and validation activities;

iii. Summary of the facilities, equipment, systems, processes on site and the qualification and validation status;

iv. Change control and deviation management for qualification and validation;

v. Guidance on developing acceptance criteria;

vi. References to existing documents;

vii. The qualification and validation strategy, including requalification, where applicable.

1.6. For large and complex projects, planning takes on added importance and separate validation plans may enhance clarity…”

The Validation Master Plan is a crucial tool for the proper planning of validation activities, including those accompanying the design processes.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.