Validation master plan

The Validation Master Plan also referenced as "VMP" is one of the key documents in the GMP (Good manufacturing practice) regulated pharmaceutical industry. Even though it is not mandatory it is the document that outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated and to provide a written program for achieving and maintaining a qualified facility with validated processes. The 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.

Common topics to be cover 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.