Rapid Microbiological Methods in the Pharmaceutical Industry

Martin C. Easter

March 19, 2003 by CRC Press
Reference - 288 Pages - 23 B/W Illustrations
ISBN 9781574911411 - CAT# PH1414

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Features

  • Provides the details of a range of rapid microbiological methods, their applications, and practical tips regarding validation, established use, and regulatory acceptance
  • Brings together expert opinion and experience in implementing microbiological methods and their application in the pharmaceutical industry
  • Covers the origins of methods and current issues facing the requirements of microbiology and its associated test methods
  • Explores how to seek better, more pragmatic methods for the assessment of microbiological hazards and risks to ensure product and consumer safety
  • Summary

    In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more.

    Martin Easter and his panel of experts:

    § Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance
    § Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods
    § Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety

    The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in Rapid Microbiological Methods in the Pharmaceutical Industry will help you find better solutions to ensuring the microbiological safety of pharmaceutical products.

    Features