Dr Marcel Goverde, MGP Consulting
Although the microbiological testing of non-sterile drug products and raw materials are clearly defined by the Pharmacopeia there are still some challenges which can appear during development or routine testing. Therefore, it is up to the pharmaceutical company to have clear written procedure on the method itself as well as on the handling of special cases. The goal of this webinar is to give an overview of the methods described in Ph. Eur. chapter 2.6.12 and 2.6.13 or USP chapter <61> and <62>. Additionally, a short introduction to the new method for the testing of Burkholderia cepacia complex drafted in USP chapter <60> is given.
The webinar targets to new staff who are in relation of pharmaceutical microbiology, but also to QA or QP who need to evaluate the data gathered by their microbiologicwal lab or CMO as well as regulatory staff in charge of microbiological specifications.
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This webinar aims at giving you a comprehensive but still compact overview about the microbiological testing methods of non-sterile products according to the harmonized chapters of the Pharmacopeia.