Validation master plan
A Validation Master Plan, also referred to as "VMP", outlines the principles and road map for maintaining a pharmaceutical manufacturing facility in a status of compliance with respect to various validations and revalidation activities involved in the qualification of a facility, defining the areas and systems and equipments to be validated, Validation Master Plan provides a written program for achieving and maintaining status of a pharmaceutical manufacturing facility in compliance with Validated Processes Validated System, Validated Equipment Area and Personnels and methods.[1][2] A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning Validation and computer System validation and calibration. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects.[3]
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. For USFDA Validation Master Plan is not mandatory but USFDA guidelines make validations of Process, Systems,Personal, Equipment mandatory. WHO good manufacturing Practices Guidelines for pharmaceutical manufacturing mentioned in details which are the topics a pharmaceutical manufacturing units are required cover in Validation Master plan, unlike USFDA.
Format
The GAMP 5 standard recommends an approach to the creation of the plan.[4]
Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system, ventilation and air-conditioning system, clean steam, compressed air, gases and vacuum system, list manufacturing equipment, building management systems, products that are planned to be validated, qualification/validation approach, process validation and cleaning validation approach, microbiological monitoring, computer Validation, calibration, maintenance, related SOPs.
References
- "Validation Master Plan Definition Regulatory aspects of Validation Master Plan". pharmacistspharmajournal.org. Retrieved 13 December 2021.
- "A Guide to Validation Master Planning". RSCAL. Retrieved 26 October 2017.
- Kenneth E. Avis; Carmen M. Wagner; Vincent L. Wu (31 October 1998). Biotechnology: Quality Assurance and Validation. CRC Press. pp. 99–. ISBN 978-1-57491-089-6.
- Guy Wingate (19 April 2016). Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance. CRC Press. pp. 86–. ISBN 978-1-4200-8895-3.