Validation Master Plan: The Streetwise Downtown Guide (single user digital version)

Dec 2002
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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.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 3.82 MB)

Paper version is not available.

Table of Contents

Table of Contents:


What is the Validation Master Plan?
Documentation Requirements, Framework, and Hierarchy

  • The Regulatory Requirements
  • Framework and Hierarchy of Documents
  • Streamlining the Document Flow

    Avoiding Duplication and Redundancy
  • Integrated Validation
  • Risk Analysis
  • General Protocols
  • Avoiding the Pitfalls

  • About the Authors

    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.