USP / Microbiological Enumeration and Examination of Non-Sterile Products - Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms - Webinar (Recorded)

Why Should You Attend:

In May 2009 the United States Pharmacopeia (USP), revision 32, implemented the long-awaited separation of USP General Chapter < 61> Microbial Limit Tests into two new chapters, i.e., USP < 61> Microbiological Examination of Nonsterile Products: Microbial Enumeration, and USP < 62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. As part of these two revised chapters, USP < 61> and USP < 62>, changes were made within the areas of sampling, quantities of final product required for testing and the media to be used for this testing. In addition, acceptance criteria have changed when recording acceptable microbiological results.

The monographs for non-sterile products reference these tests, e.g., USP < 1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP < 61> and < 62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness testing, environmental monitoring and utilities testing.

Alternative automated and rapid microbiological test methods, which may be utilized in lieu of the USP pharmacopeial method, will also be examined as part of USP < 61>/< 62> and examples provided.