Choosing between genotypic and phenotypic method for microbial identification

Microbial identification is one of the microbiological tests required in pharmaceutical microbiology quality control. It is a regulatory requirement to identify microorganisms as part of root cause investigation on cases of sterility test failure or determining out of specifications microbial limit tests. In general, there are two methods that can be used for microbial identification, either phenotypic or genotypic. Each method has its advantages and disadvantages. The FDA’s "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice", released in 2004, indicated the value of genotypic method. This webinar will explore the differences between phenotypic and genotypic method and how to choose between them for microbial identification.

In this webinar, we discuss:

  • The advantages and disadvantages of each method
  • Different technologies currently available
  • Basic requirements for validating a microbial identification method
Pia Darker

About the presenter

Pia Darker is a Global Senior Product Manager for the Pharmaceutical Analytics division of Thermo Fisher Scientific. With over 15 years of experience, Pia has previously succeeded in the company as Senior Support Specialist and Field Applications Specialist. She holds degrees from the University of Santo Tomas, National University of Singapore, and Henley Business School.

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