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.But the barriers are weakening and the market is shifting more towards a risk based – ‘quality by design’ – approach. This new approach is encouraged by the FDA and the EMEA (European Medicines Agency).
The climate for implementation of Rapid Microbiological Methods have not been as favourable as it is today in the pharmaceutical industry.
Dr. Michael J. Miller is an expert in pharmaceutical microbiology and the design implementation and validation of (new) rapid microbial methods. 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. Dr. 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. 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 http://rapidmicromethods.com (currently 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. His laboratory 1st used aseptically cut slices of potato as a solid culture medium, and later turned to liquid culture supplemented with gelatin, which was subsequently poured into glass plates and allowed to solidify. this system allowable the scientists to get pure cultures of the bacteria that were found to be growing in colonies on the surface of the plates.
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. 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.
Method validation is used to confirm that an analytical procedure used for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated before implementing into routine use and this is especially true for novel technology platforms such as rapid microbiological methods
Although some state otherwise but, today’s regulatory authorities encourage the use of rapid microbiological methods! When applicable, they have put policies in place that provide guidance on how to get a new method approved. Because there are different regulatory perspectives on rapid microbial methods implementation, a company should understand what each regulatory body expects with regard to validation, submission and implementation strategies. In the previous article, a number of implementation perspectives from the U.S. Food and Drug Administration were discussed. In this article, the focus in on the European Medicines Agency (EMA) and their expectations on the introduction of new rapid microbiological methods technologies.
Some regulatory authorities rely on the published literature as a means of staying up-to-date with new technologies that are being introduced, in addition to which companies are implementing these technologies in their manufacturing facilities.
Rapid Microbiological Methods will significantly impact the future of microbiology within the pharmaceutical and biotech industries. Rapid methods are becoming a major focus of discussions at professional microbiology and manufacturing science and technology meetings around the world. When Dr. Miller attended the 5th Annual PDA Global Conference on Pharmaceutical Microbiology in Washington, DC. End-users, regulators and pharmacopoeial expert committee members provided their experiences and perspectives on the future of Rapid Microbiological Methods implementation. Dr. Miller presented a case study on Rapid Microbiological Methods validation and taught a full day training course on the subject. In this final article in this series, an overview of the discussions that had taken place is given.