Inspectional Guidance-Laboratory Facility and Analytical Review
调查指导-实验室设施和分析审查
1.Review QC records for proper/validated sterilization of all equipment and media used during the sterility test method: manifold/ steritest; rinse fluid, culture media, canister kits, etc.
检查QC记录，以便对无菌测试方法中使用的所有设备和介质进行适当/有效的灭菌：流形/灭菌试验;冲洗液，培养基，滤罐套件等
2.Review the EM data acquired during sterility testing (i.e., settling plates, RODAC), simulation system controls, etc. What are the microbial species and its determined normal habitat (i.e., water, plants, people, etc?)
检查在无菌测试期间获得的EM数据（即，沉降板，RODAC），模拟系统控制等。什么是微生物种类及其确定的正常生长的地方（即水，植物，人等？）
3. Review training records and qualification of analysts performing the test; interview and/or observe analysts
审查执行测试的分析员的培训记录和资格;采访和/或观察分析员
4.Review the qualification of the bio-clean room facilities or isolator chamber used during testing. Are there any leaks in the gloves, improper sanitization of product container before placement into work station or isolator? Has the isolator been evaluated for leaks?
审查实验期间使用的生物洁净室设施或隔离室的资格。在放入工作站或隔离装置之前，手套是否有任何泄漏，产品容器是否消毒不当？是否对隔离装置进行了泄漏评估？
5.Review cleaning and sterilization requirements for reusable glassware and equipment. Poorly cleaned glassware will make sterilization of equipment more difficult and possibly shelter trapped microbes from the killing effect of the sterilant.
检查可重复使用的玻璃器皿和设备的清洁和灭菌要求。清洁不良的玻璃器皿会使设备的灭菌更加困难，并且可能使受限的微生物免受消毒剂的杀灭作用。
6.Review laboratory areas used for sub-culturing the sterility test medium onto enrichment plates. Cluttered work space or un-sanitized surfaces may cause plate contamination.
检查用于将无菌测试培养基再培养到富集平板上的实验室区域。杂乱的工作空间或未消毒的表面可能会导致板污染。
7.Check the original plates used for isolation for possible pre-existing contamination (i.e. growth in non-streaked locations on the agar surface, subsurface growth)
检查用于分离的原始培养基琼脂平板，可能存在污染（如生长在琼脂表面非划线培养的地方、琼脂下表面）
8.Check to see if the medium had been recalled or has had past problems with contamination during manufacturing.
检查该培养基是否已被召回或在生产过程中曾出现污染问题
9.It may be necessary to perform a genotype identification on the two isolates (product source and manufacturing area isolate) if they are the same species.
如果两种分离培养出来的微生物（产品和生产区域分离出的菌）属于同种时，有必要进行基因鉴定
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 6-实验室设施和分析审查
