Activities of the USP Microbiology Subcommittee of Revision During the 1995 - 2000 Revision Cycle

This article is a comprehensive review of the published activities of the Microbiology Subcommittee of the USP Committee of Revision for the 1995 - 2000 revision cycle. The activities of this revision cycle were designed to position USP activities in microbiology that will be useful as technology advances. In addition to reviewing the changes accomplished, this article discusses the rationale for many of the changes and some background information on new initiatives underway. Where appropriate, changes in the USP that did not fall under the direct purview of the MCB Subcommittee but of interest to the microbiology community are also discussed. control of processes. This scope does not extend to drug or product monographs, which are handled by other Subcommittees, although the Microbiology Subcommit- tee does support the development of microbial require- ments for all monographs. Similarly, antibiotics are handled by a separate subcommittee, while the respon- sibility for water is shared with the Water and Parenteral Subcommittee (especially in the area of microbiologi- cal control of pharmaceutical waters). The MCB Subcommittee works within the structure of the USP, developing or revising chapters as deemed necessary. It is important to understand the purpose and application of USP in this regard. Firstly, there are two distinct types of standards encompassed by USP: expert standards and guidance documents. USP stan- dards, microbiological methods included, are referee tests that have a scientific as well as a legal standing; they are expert standards, not consensus standards. Secondly, they are not batch release methods nor are they quality control methods. If, for example, a phar- maceutical product does not fulfill the requirements of the monograph, then it is "mislabeled" or "adulterated" and the regulatory agencies can take action based on these two provisions of the Food, Drug, and Cosmetic Act. Given this legal status of compendial tests, changes to any chapter are made only after careful consideration. Similarly, the guidance documents in USP are widely held as a reference guide to industry, and changes to an official chapter are very slowly introduced.