The second in this series of four books. Provides current, practical techniques that focus on considerations in the preparation and monitoring of aseptic manufacturing, taking into account the national and international requirements, and guidelines concerning the validation of aseptic processing. The guide also includes an excellent Manufacturing and Testing Master Batch Record, and 25 extremely valuable charts, graphs, and figures.

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Format: PDF (1 file - 13.1 MB)

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Table of Contents:

Introduction
Principles
Risk Analysis (HACCP)
Documentation and Qualification
Qualification and Training of Personnel
Scope of Validation
Requirements
Release Requirements
Documentation
Authorization
Example of a Master Batch Record for the Media Fill Validation
Manufacturing and Testing Record (Master Batch Record)
Cited References
Further Reading
Acknowledgements
Biography

About the Author

Dr. Michael Jahnke studied biology at the universities of Bielefeld and Hanover, Germany. He obtained his Ph.D. from the Institute of Microbiology at the University of Hanover. From 1990-1994, he was Head of the Biology Department at IBR Forschungs GmbH and is now Head of the Quality Control/ Microbiology Department at Pharma Hameln Gmbh. In this position, he is responsible for hygiene aspects, microbiological quality control, process validation, and risk analysis strategies. He is a member of the American Society for Microbiology (ASM), the Parenteral Society, the Deutsche Gesellschaft fur Hygiene und Mikrobiologie (DGHM), and he serves on the Editorial Board of European Journal of Parenteral Sciences of the Parenteral Society.

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