EP 5.1.4 非无菌制剂和药用物质的微生物质量标准(中英文).docVIP

01/2011:50104 5.1.4. MICROBIOLOGICAL QUALITY OF NON-STERILE PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE (1)?非无菌制剂和药用物质的微生物质量 ? The presence of certain micro-organisms in non-sterile 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. 在非无菌制剂中如果存在某些微生物，可能会降低或抑制药物的治疗活性，可能会对病人健康有潜在不良影响。 ? Manufacturers therefore have 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. 因此，生产商应在药品生产、存贮和销售过程中遵守现行GMP指南，来保证制剂的微生物在一个较低的水平。 ? Microbial examination of non-sterile products is performed according to the methods given in general chapters 2.6.12 and 2.6.13. Acceptance criteria for non-sterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts/moulds count (TYMC) are given in Tables 5.1.4-1 and 5.1.4-2. Acceptance criteria are based on individual results or on the average of replicate counts when replicate counts are performed (e.g. direct plating methods). 非无菌产品微生物检查应依据通则2.6.12和2.6.13中指定的方法进行。非无菌制剂的细菌数（TAMC）和霉菌酵母菌总数（TYMC）可接受标准见表5.1.4-1和表5.1.4-2。可接受标准是基于单个计算结果或多个计数（例如碟式直接计数法）结果的平均值。 ? When an acceptance criterion for microbiological quality is prescribed it is interpreted as follows: 可接受标准的解释如下 —???????101?CFU: maximum acceptable count = 20; —???????101?CFU:：最大可接受计数结果=20 —???????102?CFU: maximum acceptable count = 200; —???????102?CFU:：最大可接受计数结果=200 —???????103?CFU: maximum acceptable count = 2000, and so forth. —???????103?CFU:：最大可接受计数结果=2000，依此类推 ? Table 5.1.4.-1 includes a list of specified micro-organisms for which acceptance criteria are set. The list is not necessarily exhaustive and for a given preparation it may be necessary to test for other micro-organisms depending on the nature of the starting materials and the manufacturing process.