Inspectional Guidance-Sample Data Review – Microbial Growth Indicated
When you encounter inspectional evidence that the firm has manufactured microbiologically contaminated product, the few suggestions listed below should help you evaluate and proceed with this information.
当您遇到检验证据，表明公司已经生产出受微生物污染的产品时，下面列出的一些建议将帮助您评估和处理这些信息。
1. Documentation- Review and obtain copies of all records for lots indicating contamination; determine if there are other lots manufactured either before or after the “bad” lot(s); Review all associated activity and equipment related to the contaminated lot. There may be common water, mixing tanks. Piping, raw material, sterilizers, filters, etc that may have been cross contaminated and transferring microbes to subsequent lots of products.
文件 – 审查并获取指示污染的批次所有记录副本;确定在“坏”批次之前或之后是否制造了其他批次;检查与污染批次相关的所有相关活动和设备。可能有普通水，混合灌。管道，原材料，灭菌器，过滤器等可能已被交叉污染，并将微生物转移到随后的大量产品中。
2. Review current established validation studies for product/component sterilization (disinfection for non-sterile products); has there been any equipment changed or modified; has there been a change of personnel or training; any new source material for equipment (vent filters, gaskets, filter manufacturer, etc.); any processing changes or room modifications, construction elsewhere in the facilities, etc.
审查目前已建立的产品/组件灭菌验证研究（非灭菌产品的消毒）;是否有任何设备被更改或修改;是否有人员或培训的变化;任何新的设备来源材料（通风过滤器，垫圈，过滤器制造商等）;任何处理变更或房间修改，设施其他地方的建设等。
3. Review of Environmental monitoring (EM) procedures and results for manufacturing and laboratory area- Would the product contaminant grow on the EM medium; was the product contamination found in the manufacturing area; Growth promotion potential of contaminant in other medium (i.e., TSB and Thio)
审查制造和实验室区域的环境监测（EM）程序和结果 -产品污染物是否在制造区域发现；污染物在其他介质（即TSB和THIO）中的生长促进潜力。
4. Speciation- Record and copy the method of identification (i.e. API, Vitek, etc); Determine if there were possible secondary contaminants that were not identified or recorded (check original plates, or isolates); verify accuracy into the LIM system.
形态-记录并复制鉴定方法（即API、VITEK等）；确定是否存在未被鉴定或记录的可能二次污染物（检查原始板或隔离物）；验证LIM系统的准确性。
5. Determine potential source- Staphylococcus (skin, insect, etc); Pseudomonas (water, plants, etc) ; yeast and mold (spores) (environmental)
确定潜在的来源 – 葡萄球菌（皮肤，昆虫等）;假单胞菌（水，植物等）;酵母和霉菌（孢子）（环境）
6. Review investigation report- Source of contamination; Corrective action; repeat testing and release; does it include related lots and ancillary systems? Was the product rejected or released? If released ask why? Evaluate justification.
审查调查报告 – 污染源;纠正措施;重复测试和放行;是否包括相关批次和辅助系统吗？产品是否被拒绝或被放行？如果放行问为什么？评估理由。
本文来自Pharmaceutical Microbiology Manual2014
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原文始发于微信公众号（药品微生物检测）：Inspectional Guidance 4-样本数据审查 – 微生物指示性生长
