Validation Master Plan (VMP)

From WikiBioPharm

A Validation Master Plan (VMP) is generally created before the start-up of a facility project.

• Lists the critical utilities and equipment
• Outlines the Qualification/ Validation approach
• Establishes the regulated areas
• Defines the validation approach of the facility including, if used, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Often includes general acceptance criteria for all critical utility systems and equipment
• Often includes (or refers to a seperate document that includes) additional programs, such as training, calibration, and preventive maintenance

The scope of a VMP is most often either an entire facility or a complex validation project.