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Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>

9 February 2010, United States


Introduction
The Microbial Limits Tests of the three major pharmacopeia are in the final processes of harmonization and are scheduled to be fully implemented in 2009. These provide guidance on compendial testing of bioburdens and specified organisms and guidance on setting specifications. This presentation will cover the tests in board overview and discuss the differences between compendial tests for specified organisms and the manufacturer's obligation to minimize the presence of objectionable organisms.

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