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
:
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 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