Microbiological Validation Master Plan (single user digital version)

Sep 2004
PDA Item Number
PDF Single user
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This booklet covers the below chapter that is taken from PDA's bestselling Microbiology in Pharmaceutical Manufacturing, 1st Edition and provides practical advice for anyone interested in current aspects of microbiology in pharmaceutical manufacturing.

Microbiological Validation Master Plan

This booklet describes the contents of the Microbiological VMP and the factors that influence the validation requirements. These elements include factors affecting the testing carried out, the frequency and the extent of this testing, the acceptance criteria, and the need for revalidation.
As the reader progresses through this booklet it is intended that he or she will gain an appreciation of the thought processes and the planning required within the microbiology laboratory to support the company's overall validation effort.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 5.22 MB)

Table of Contents

Table of Contents :

I. Abstract

II. Introduction

III. The Essentials of a VMP

  • Process and Facility Description and Design
  • Scope of Validation Activities
  • Process Development Consideration
  • Critical Control Parameters and Acceptance Criteria
  • Formulation Considerations and Product Specifications
  • Analytical Methods and Their Validation
  • HVAC Design and Qualification
  • Equipment and Utilities Qualification
  • Responsibilities
  • Calibration and Maintenance
  • Standard Operating Procedures for Validation Activities
  • Dealing with Deviations and Discrepancies
  • Change Control and Revalidation

    IV. The Influence of the product on Process Validation

    V. Summary
    VI. References
    VII. About the Author

  • 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.

    Other title wrote by Dr. Deeks is Validation Master Plan: The Streetwise Downtown Guide