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rapid sterility testing - Articles and news items
This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for both small and large molecule pharmaceuticals and ophthalmic products, in addition to cell therapy and tissue culture products, as an alternative to pharmacopeial sterility tests, and company success stories have been presented and published at numerous professional meetings and in a variety of scientific journals (please see the reference page at http://rapidmicromethods.com for the full titles). However, the industry as a whole has not embraced the use of rapid sterility testing as much as other microbiological applications, such as in-process bioburden, environmental monitoring and Microbial Limits testing. The reasons are varied, and have included concerns regarding return on investment, the extent of the validation plan and regulatory acceptance. Fortunately, recent changes in regulatory policy make it clear that RMMs for finished product sterility testing have a place in our industry, and it is the FDA that is leading the motivation for change.
In February 2008, the FDA published their draft guidance on the validation of growth-based RMMs for sterility testing of cellular and gene therapy products. The guidance addressed considerations for method validation and determining equivalence of an RMM to sterility assays described in Title 21 Code of Federal Regulations (CFR), 610.12 (21 CFR 610.12).
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives on the implementation of RMMs, especially from the US FDA and the European Medicines Agency. Some regulatory authorities rely on the published literature as a means of staying current with regard to new technologies that are being introduced, in addition to which companies are implementing these technologies in their manufacturing facilities.
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