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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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