Rapid Microbiological Methods in the Pharmaceutical Industry

Covers the how-tos for applying an effective system to assess the real microbiological hazards and hence quantify realistic risks. This work details monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety.

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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.

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