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发帖数: 25265 | 1 http://en.wikipedia.org/wiki/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 the Food and Drug Administration
inspectors will ask you for it when they inspect your facility. An inspector
can look at the VMP and realize that the facility's validation strategy is
well thought out and organized; that there is a logical reason for including
or excluding every system associated with the validation project based on a
risk assessment. A Validation Master Plan (VMP) drives a structured
approach to validation projects that will allow you to address many problems
before they become crises. A 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 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 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.
If a pharmaceutical company within the US wants to pass an FDA audit a
process validation master plan, an equipment validation master plan, a
cleaning validation master plan and a computer validation master plan are
very necessary.
[edit] External links"The Validation Master Plan: How to Write It and How to
Make It Work for Your Company"
Quality Management Systems - Process Validation Guidance, Global
Harmonization Task Force
GMP and Validation
SOP and Validation | a*i
发帖数: 1652 | 2 实施起来细节无穷多，很多情况下需要自行判断，所以漏洞也是难以避免。和FDA打交
道的经验真的很重要。 |
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