This book has been prepared to address the requirements which are stated in
the Guide to the Knowledge and Practical Experience Required by Qualified
Persons in the Pharmaceutical Industry (the "Study Guide")
in relation to pharmaceutical microbiology.
This reference guide will help QP candidates prepare for the assessment board,
as well as refresh QPs who are faced with actual or potential microbiology problems.
This guide additionally serves as a useful starting point for QPs who may wish
to explore pharmaceutical microbiology in greater depth than simply what is
required by the Study Guide.
Book written in September, 2007.
Original Price US$250 PDA
Member, US$309 Nonmember, US$180 Government
Sale prices are already
displayed and will be reflected during checkout
Table of Contents:
Click here to download >>>Detailed Table of Contents
Introduction (Click here to
download >>>Introduction )
1. Essential Background
2. Contamination Control
3. Microbiological Quality
4. Water Microbiology
5. Manufacture of Sterile Products
Sterilisation and Depyrogenation
8. Endotoxins and the
9. Simulation (Media Fills)
10. Preservative Efficacy
12. Microbiological Assay
Appendix by Bruce
About the Authors
Dr. Nigel Halls is Executive Director for Science and
Technology and a founding partner of IAGT (International Academy of GMP
Training) Ltd. - one of Europe's fastest growing training and consultancy
organisations. He has degrees in Microbiology from the Universities of Bradford
and Bath (UK) and has worked in the pharmaceutical and sterile medical devices
industry for many years. His principle professional interests are sterile
manufacture, manufacture of aqueous pharmaceutical products, and design, control
and monitoring of pharmaceutical water systems.
Dr. Halls` extensive publications include Achieving Sterility (1994)
and Microbiological Contamination Control in Pharmaceutical Clean Rooms
(2004). He recently scripted multi-media pharmaceutical training programmes for
MVI International. He serves as member of the Fellowship and Membership
Committee of the Institute of Biology (UK) and is an active member of PDA. At
the time of writing he is serving as a member of the Special Task Group charged
with revising PDA Technical Report 1, Validation of Moist Heat Sterilization
Processes: Cycle Design, Development, Qualification and Ongoing Control.
Bruce Vernon is a versatile quality systems, regulatory and
product development consultant with very wide ranging experience. An
immunologist by training and chartered biologist. Bruce gained his Master`s
degree in 1995 while working with the UK Blood Transfusion Service (BTS) after
his initial training in Medical Laboratories and some time abroad working as
technical advisor to the Nepal Red Cross Blood Transfusion Service.
Bruce has 30 years experience within GLP and GMP licensed Facilities (FDA and
MHRA), the last 10 years at senior management level within the biotech/pharma