Editor’s Note: The presence of microbial contaminants poses a serious threat to raw material, drug substance, and drug product quality and patient safety. Bioburden levels must be strictly controlled in order to prevent serious product quality problems and adverse patient reactions.
FDA has spelled out requirements in its CGMP code (1) and in more recent risk-based guidance documents (2). The United States Pharmacopeia (USP) set standards with USP Chapters <62>, Microbiological Examination of Non-Sterile Products and <1111> Microbiological Examination of Non-Sterile Products Acceptance Criteria (3,4).
However, subsequent USP guidance (USP <1115>) focused less on in-process and post-production microbial testing and more on facility, equipment, and process design and operation. In this article, two members of USP’s expert committee on microbiology , suggest ways in which USP <62> and <1111> might be improved, to more closely reflect today’s manufacturing realities and subsequent guidance. Before making formal suggestions for change, they are seeking industry opinion. Please contact them to discuss these issues, share your thoughts, or for more information.