Inspectional Guidance-Manufacturing Facility Review   调查指导-生产设备审查   1. Aseptically filled pharmaceuticals药品无菌灌装 Check environmental monitoring (EM) data taken from production areas and the testing environment (i.e., S-T-A, settling p…

  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 f…

  Inspectional Guidance-How to Investigate a Microbiological OOS test result(s)   调查指导-如何调查微生物OOS测试结果   1. When a firm has an end product test result that indicates a failure (USP test failure, OOS, etc) the inevitable question is –Wer…

  Inspectional Guidance-Sample Data Review – Microbial Growth Indicated 调查指导-样本数据审查 – 微生物指示性生长   When you encounter inspectional evidence that the firm has manufactured microbiologically contaminated product, the few suggestions listed belo…

  Inspectional Guidance-Sample Data Review – All Negative Results   调查指导-审查样本数据- 所有阴性结果   What to review when all the firm’s Sterility and/or Microbial Limits test results indicate no microbial growth and you need to know whether this …

  Inspectional Guidance-Microbiological Issues for Inspection of Pharmaceutical Manufacturing Facilities 调查指导-药品生产设施的微生物调查   1. Product Sterilization or bioburden reduction stage and validation- Aseptic/Filtration, steam, ETO, radiation, an…