Validation Master Plan

A Validation Master Plan, also referred to as "VMP", outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects.

Food and Drug Administration inspectors often look at VMPs during audits to see whether or not a facility's validation strategy is well thought-out and organized. A VMP should have logical reasoning for including or excluding every system associated with a validation project based on a risk assessment.

Common topics to be covered in a Validation Master Plan: Introduction, Scope of the VMP, Responsibilities, Description of facility and design, Building and Plant Layout, Construction materials, Cleanliness Zoning and room pressure Concept, Storage Areas, Personnel, Training and Personnel Flow, Material and Waste Flow, Water and solid waste handling, Infrastructure and Utilities, Water qualities, Heating, ventilation and air-conditioning (HVAC)Clean Steam, compressed air, gases and Vacuum System, Description of Manufacturing Equipment,Building management systems, Products to be manufactured, Qualification/validation approach,Process Validation and Cleaning validation approach, Microbiological Monitoring and Computer Validation, Calibration, Maintenance, Change Control, Suppliers Inspections, Internal audits and other key SOPs.