USP（1111）-非无菌产品的微生物检验-药物制剂和药用物质的验收标准.pdfVIP

Printed on: Thu Mar 21 2019, 09:56:48 am Printed by: John Schlemmer Currently Ocial as of: 21-Mar-2019 Ocial Prior to 2013 DocId: GUID-5D1EDF19-6C70-4F74-A474-07D9B25B1C58_1_en-US Printed from: /uspnf/document/GUID-5D1EDF19-6C70-4F74-A474-07D9B25B1C58_1_en-US?highlight=1111 © 2019 USPC 〈 1111〉 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE The presence of certain microorganisms in nonsterile preparations may have the potential to reduce or even inactivate the therapeutic activity of the product and has a potential to adversely affect the health of the patient. Manufacturers have therefore to ensure a low bioburden of nished dosage forms by implementing current guidelines on Good Manufacturing Practice during the manufacture, storage, and distribution of pharmaceutical preparations. Microbial examination of nonsterile products is performed according to the methods given in the texts on Microbial Enumeration Tests 〈61〉 and Tests for Specied Microorganisms 〈62〉. Acceptance criteria for nonsterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) are given in Tables 1 and 2. Acceptance criteria are based on individual results or on the average of replicate counts when replicate counts are performed (e.g., direct plating methods). When an acceptance criterion for microbiological quality is prescribed, it is interpreted as follows: 1 10 cfu: maximum acceptable count = 20; 2 10 cfu: maximum acceptable count = 200; 3 10 cfu: maximum acceptable count = 2000; and so forth. Table 1. Acceptance Criteria for Microbiological Quality o