Validation Master Plans (VMPs) are an integral part of the documentation required for process development and validation.

Validation documents are used to systematically and accurately record the controlled operating limits of manufacturing processes. Validation can also be used to support any subsequent changes to a manufacturing process, demonstrate equivalence, track process development, and scale-up.

The library of validation documentation that pharmaceutical companies are required to complete and maintain is extensive and can include:

  • Validation Master Plan and Individual Validation Plans (for methods, process, equipment, facilities, utilities, cleaning, etc.)
  • Validation protocols including DQ, IQ, OQ and PQ
  • Process development reports
  • Technical reports

A Validation Master Plan (VMP) documents the way a manufacturer will operate, who has control over various aspects of the validation activities, and how key activities such as production, quality assurance, quality control and personnel management will be directed.

A VMP provides the guidance for performing the appropriate validation process of systems, equipment and analytical methods and whilst not a mandatory document, it is generally requested (and expected), and viewed favourably during audits and inspections.