Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle

Dr Scott VW Sutton from Microbiology Network and member of the MSA Expert Committee and Dr Radhakrishna Tirumalai, Principal Scientific Liaison for the General Chapters and USP Staff Liaison for the MSA Expert Committee published an article about the activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010 revision cycle.

This cycle involved the completion of several harmonization efforts, including Sterility Tests, Microbial Limits Tests, and the Bacterial Endotoxins Test. In addition, USP continued in its leadership of laboratory practices with informational chapters (both new and revised) in several areas of laboratory activity. The EC had 9 new general chapters under development and managed 7 monographs, 3 of which were new this cycle. In addition to reviewing the changes accomplished, this article discusses the rationale for many of the changes and some background information about new initiatives now underway. Where appropriate, the authors discuss changes in USP that did not fall under the direct purview of the MSA EC (whose responsibility included 7 monographs and 37 general chapters) but are of interest to the microbiology community.

Please see the article "Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle" for further details.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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