USP371111非无菌药品微生物检查：药用制剂和药用物质可接受标准(中英文).docVIP

USP37 1111非无菌药品微生物检查:药用制剂和药用物质可接受标 准(中英文) (2014-06-06 14:19:33) 转载▼ 分类：食品药品 ＜1111＞ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE 非无菌药品微生物检查：药用制剂和药用物质可接受标准 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 finished dosage forms by implementing current guidelines on Good Manufacturing Practice during the manufacture, storage, and distribution of pharmaceutical preparations. 在非无蘭制剂屮如果出现特定的微生物，可能会降低其至失去治疗活性，对患者健康产生潜在负 面影响。因此，生产商需要通过在生产、存贮制剂的过程屮实施GMP现行指南，保证制剂的生 物负载在一个较低的水平。 Microbial examination of nonsterile products is performed according to the methods given in the texts on Microbial Enumeration Tests and Tests for Specified 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). 非无蘭药品的微屯物检齊应根据＜61微生物限度检齊＞和＜62控制阐测试＞进行。非无尚药品的 可接受标准根据表1和表2屮给定的“总有氧菌计数TAMC”和“总酵母阐和霉蘭计数TYMC” 进行判定。是否符合可接受标准砬蕋于单个结果或S于重复计数(例如，平皿法)的平均结果来 进行判定。 When an acceptance criterion for microbiological quality is prescribed, it is interpreted as follows: 如果指明了微生物质景的可接受标准，则含义如下 10i cfu: maximum acceptable count = 20; 101cfu：最大可接受计数=20 102 cfu: maximum acceptable count = 200; 102cfu:最大可接受计数=200 103 cfu: maximum acceptable count = 2000; and so forth. 表1非无菌制剂微生物质量可接受标准103cfu： 表1非无菌制剂微生物质量可接受标准 Table 1. Acceptance Criteria for Microbiological Quality of Nonsterile Dosage Forms Route of Administration 摄入途径 Total Aerobic Microbial Count 总 有氧菌计 数 (cfu/g or cfu/mL) Total Combined Ye