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- One event which increased FDA awareness of the potential for cross contamination due to inadequate procedures was the 1988 recall of a finished drug product, Cholestyramine Resin USP. 导致FDA对由于不满足要求的过程导致交叉污染的可能性的进一步关注的案例是,1988年对成品药消胆胺树脂USP的撤回。
- Discussion on the Shelf-life of Finished Drug Products 关于药品制剂有效期的商榷
- finished drug product 药物制成品
- Is the filter membrane compatible with the drug product? 滤膜与产品兼容吗?
- The retention Samples of the Drug Product must be stored at the Site that releases the Drug Product Batch. 制剂产品的留样必须保存在放行制剂产品批的工厂。
- CQAs are generally associated with the drug substance, excipients,intermediates, and drug product. 一般来说,关键质量属性(CQA)是与药物活性成分,赋形剂,中间体和药品相关的。
- She is an active member of the FDA foreign inspection cadre, participating in both API and drug product inspections. 她是FDA外籍检查成员组的积极成员,曾参加了原料药和成品药的检查工作。
- Approximately 25 percent of those are lyophilized drug products. 大约25 %25的受访者是冻干药物产品。
- EMEA :Impurities in new drug products(ICH Topic Q3b(R)). 中国药典2005年版二部附录增修订内容汇编。
- The total organic impurities for the drug product or drug substance is the sum of all impurities equal to or greater than their individual QL. 3、所有的没有记载的杂质,以及;4、总杂质。总有机杂质是指所有达到或超过其自身定量限度的杂质的总量。
- Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. 已经批准使用的成分、药品包装和密封件的流转应本着最先批准最先使用的原则。
- Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. 任何用于药品生产、加工、包装或贮存的建筑物须保持良好状态。
- If we all muck in we'll soon finish the job. 如果我们大家都动手,一会儿就可以干完这件事。
- Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. 一旦批准,则申请者可以生产和销售该仿制药以向美国公众提供安全,有效,廉价的替代品。
- Approved Drug Products with Therapeutic Equivalence Evaluations/Orange Book. 报告处方药物信息。
- The section of the application that includes the justification of the drug product specification (P.5.6) is a good place to summarise the control strategy. 适于在申请文件中含药物质量标准合理性论证这一章节中概叙控制策略。
- I was frantic to finish the report on schedule. 我十万火急地要按预定时间完成报告。
- I finished work unexpectedly early. 我的工作意外地提早做完。
- The work must be finished in one way or another. 这件事必须设法做好。
- It took us an entire week to finish painting the home. 它花去了我们整整一星期的时间才把房子粉刷好。
