Validating rapid microbiology methods

This new approach is encouraged by the FDA and the EMEA (European Medicines Agency). Internationally recognized microbiologist and currently President of Microbiology Consultants, LLC.He is known for his knowledge on Rapid methods and providing clear scientific, quality solutions for the (pharmaceutical) industry. Miller has over twenty four years of experience – R&D projects, quality of production programs, consulting and business development- in leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc.This is especially true if the traditional method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorisation.Of all industrial microbiology sectors the pharmaceutical sector is perhaps the one most restricted, guided and determined by regulatory requirements.This is applicable not solely to what and when samples ought to be tested, but also what method should be used.Whereas strict protocols are helpful in providing clear guidelines and requirements for testing, they can also act as a barrier of new microbiological detection techniques.

Rapid microbiological methods have been implemented by multiple companies around the world.In some cases, it is essential to work with regulatory authorities in order to effectively introduce a new technique as a replacement of traditional microbiological methods.As author over a hundred technical publications and numerous presentations within the area of rapid microbial detection, editor of PDA’s reference book of Rapid Microbiological strategies, and the owner of the most complete website dedicated to rapid microbial detection) we are happy to share a series of his articles that previously appeared in European Pharmaceutical Review.EXPERTISE AND CURRICULUM VITAE (CV) When microbiology was in its early stages of development, scientists used liquid media for the cultivation of microorganisms.

For people who were in want of a method to segregate individual varieties of organisms or pure cultures, using liquid media had many big disadvantages.

This was the case for Dr Koch, who, in 1881, was determined to search out an alternate methodology for his experiments.


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