The Validation Master Plan is used for many different purposes by different
companies and by different production sites within the same company. Within
the countries governed by the Pharmaceutical Inspection Cooperation Scheme (PICS),
there is a current move to define what is required of a VMP.
This book discusses these proposals and defines ways the VMP can be used to
gain maximum benefit from a validation project. It describes the core-tool nature
of the VMP, and ways to use if as a framework and hierarchy for all the documentation
required within integrated engineering, procurement, construction, and validation
projects. It clearly shows how tangible benefits can be gained by using the
VMP this way.
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The Regulatory Requirements
What is the
Validation Master Plan?
Documentation Requirements, Framework, and
Framework and Hierarchy of Documents
Streamlining the Document Flow
Avoiding Duplication and Redundancy
About the Author
Dr. Trevor Deeks
has 22 years of experience in pharmaceutical manufacturing,
formulation development, QA management, process scale-up, and validation project
management of projects ranging from small single systems to large aseptic
filling, biotech, and tabletting facilities. He has worked as a consultant
providing training, performing many audits and mock inspections, and
troubleshooting and problem solving for a number of major pharmaceutical
companies. Dr. Deeks has also acted as an auditor for both the WHO and UNICEF.
Dr. Deeks joined Fluor Limited in November 2000 as Manager of Validation and
Regulatory Compliance, Europe, having previously held senior positions with
Raytheon, Boehringer Ingelheim, and Marion Merrell Dow (now part of Aventis). He
is a Qualified Person under EC legislation and is a registered pharmacist. Dr.
Deeks has published over 30 papers in peer reviewed journals and has contributed
to a number of books including the Pharmaceutical Codex. He is an active
presenter at PDA, ISPE, Royal Pharmaceutical Society, and Parenteral Society
conferences and he has sat on a number of BSI, CEN, ISO, and European
Pharmacopoeia Commission expert working groups. He is a Past Chairman of the
Parenteral Society and was Editor-in-Chief of the European Journal of
Parenteral Sciences from its launch in January 1996 until the end of 1999.