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)VIP免费

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. 在非无菌制剂中如果出现特定的微生物，可能会降低甚至失去治疗活性，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、存贮制剂的过程中实施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 Enu meration Tests 61 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). 非无菌药品的微生物检查应根据<61 微生物限度检查>和<62 控制菌测试>进行。非无菌药品的可接受标准根据表1 和表2 中给定的“总有氧菌计数 TAMC”和“总酵母菌和霉菌计数 TYMC”进行判定。是否符合可接受标准应基于单个结果或基于重复计数（例如，平皿法）的平均结果来进行判定。 When an acceptan...