The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals A Five-Year Retrospective Leading to the Future

The authors review the role of USP in the development and implementation of microbiological methods for the assessment of the quality of pharmaceuticals, excipients, drug substances, and drug formulations (sterile and nonsterile) by summarizing the considerable activities of the Microbiology Subcommittee in the 1995‐2000 USP revision cycle. These activities are designed to support manufacturers and regulators in ensuring the microbiological quality of products in the twenty-first century. he traditional framework of the role of microbiology in the United States Pharmacopeia (USP) for the assessment of quality of pharmacopeial articles is illustrated in Figure 1. The application of advances in microbiological science that supports that framework has lagged behind the application of advances in chemical and physical sciences. The expansion and globalization of pharmaceutical markets have made microbiology a critical tool for manufacturers to use to ensure the microbiological quality of their products and for regulators to ensure that compliance is effectively protecting patients who are using the products. The role of USP, a nongovernmental, not-for-profit organization, is to develop microbiological public standards that, along with other requirements, ensure the consistency of products from batch to batch as well as the microbiological quality of the products. The USP process is open, transparent, and effective and involves interested parties from industry, government, and academia. The publication of proposals for the microbiological requirements in monographs or general chapters in Pharmacopeial Forum (PF) generally has elicited considerable comment from all interested parties because, in one way or another, microbiology is involved in the quality continuum that stretches from raw materials manufacture to the final product ready to be distributed in the marketplace. Additional support of the regulators and the manufacturers also is provided by the develop