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Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, this practical guide covers methods and technologies required by regulatory authorities throughout the world. Focused on compliance with the European Pharmacopeia and related regulations, the calibration of laboratory equipment, hygiene procedures, ambient monitoring, and the validation of standard microbiological methods is described in detail, usually with step-by-step protocols.
Pharmacopoieal as well as non-pharmacopoeial methods for the identification and quantification of microorganisms are discussed, including cell culture tests, selected animal test, as well as rapid methods. Dedicated chapters cover microbiological water examination and the potential for automation of standard tests. This practice-oriented refrence is an all-in-one resource for successfully setting up and running a microbiologcal quality control unit in the pharmaceuticals, diagnostics, and cosmetics industry.
List of contents
1 Introduction to microbiology
2 General conditions for the operation of microbiological laboratories
3 Calibration and qualification of devices
4 Type culture maintenance
5 Industrial Hygiene
6 Ambient monitoring
7 Quality control
8 Process validation
9 Microbiological water examination
10 Rapid microbiological methods
11 Automation in the microbiology laboratory
12 Quality assurance
13 Identification of Microorganisms
14 Cleaning, sterilization, decontamination, disposal
15 Contract testing
Appendix
Networks and associations
Recommended reading
Glossary
About the author
Michael Rieth studied biology with main focus on microbiology and biochemistry at the University of Göttingen, obtaining a doctorate at the Institute of Microbiology. In 1988 he entered into the pharmaceutical world: initially at biosyn Arzneimittel GmbH, Stuttgart, then Nordmark Arzneimittel GmbH, Uetersen and Schering AG, Berlin. From 1999 to 2014 he was Head of Biological Quality Testing at Merck KGaA, Darmstadt, then worked in the field of "Global Regulatory Affairs" until his retirement in 2020.
In 2012, he published the book "Pharmaceutical Microbiology" in German language, for which the Wallhäusser Prize was awarded the following year. In 2016, his book "Hygiene in Pharmaceutical Production" was published. The second edition of "Pharmaceutical Microbiology" followed in 2017 and his book "Endotoxins and Pyrogens" was published in 2021.
Summary
Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, this practical guide covers methods and technologies required by regulatory authorities throughout the world. Focused on compliance with the European Pharmacopeia and related regulations, the calibration of laboratory equipment, hygiene procedures, ambient monitoring, and the validation of standard microbiological methods is described in detail, usually with step-by-step protocols.
Pharmacopoieal as well as non-pharmacopoeial methods for the identification and quantification of microorganisms are discussed, including cell culture tests, selected animal test, as well as rapid methods. Dedicated chapters cover microbiological water examination and the potential for automation of standard tests. This practice-oriented refrence is an all-in-one resource for successfully setting up and running a microbiologcal quality control unit in the pharmaceuticals, diagnostics, and cosmetics industry.
