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.[1] 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.[2]
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.
Formatedit
The GAMP 5 standard recommends an approach to the creation of the plan.[3]
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.
Referencesedit
^"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–. ISBN978-1-57491-089-6.
^Guy Wingate (19 April 2016). Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance. CRC Press. pp. 86–. ISBN978-1-4200-8895-3.
validation, master, plan, examples, perspective, this, article, represent, worldwide, view, subject, improve, this, article, discuss, issue, talk, page, create, article, appropriate, august, 2017, learn, when, remove, this, template, message, validation, maste. The examples and perspective in this article may not represent a worldwide view of the subject You may improve this article discuss the issue on the talk page or create a new article as appropriate August 2017 Learn how and when to remove this template message 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 1 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 2 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 Format editThe GAMP 5 standard recommends an approach to the creation of the plan 3 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 edit 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 See also editDesign qualification Installation qualification Operational qualification Performance qualification Process qualification Verification and validation Retrieved from https en wikipedia org w index php title Validation master plan amp oldid 1189002972, wikipedia, wiki, book, books, library,
