Qualification of Microbial Identification Technology – USP <1113>
Webinar to be presented Thursday, June 28 at 2 pm EDT
Microbial identification is central to the role of the QC Microbiology lab in virtually every activity from maintenance activities (such as internal controls on the stock cultures) to investigations. However, different technologies have different capabilities with varied strengths for a specific applications. The inappropriate use of identification technology can directly lead to errors in QC Microbiology resulting in product recall.
There are a variety of different microbial identification technologies available for the QC Microbiology laboratory. Use of these in a CGMP environment requires qualification as “suitable for its intended use”, but there is little guidance on this activity beyond USP. This webinar will review the available technologies, and the guidance provided in USP <1113> “Microbial Characterization, Identification and Strain Typing”. It will conclude with concrete recommendations for design of the qualification process based on the QC lab’s role in the company and its varied needs.
Scott Sutton, Ph. D.
Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals. Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups. This service also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to cleanrooms and controlled environments.