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Validation master
plan

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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
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.

References
1. "A Guide to Validation Master
Planning" . RSCAL. Retrieved
26 October 2017.
2. 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.
3. 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
Design qualification
Installation qualification
Operational qualification
 Performance qualification
Process qualification
Verification and validation

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