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- 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。
- 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。
- 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。
- Approved Drug Products with Therapeutic Equivalence Evaluations/Orange Book. 报告处方药物信息。
- 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。
- This Standard applies to all Company Sites and Affiliates. It includes all commercial Active Pharmaceutical Ingredients, Drug Product and Medical Devices Manufactured by or for Company. 这种标准适用于所有的药品生产企业及相应的附属机构,包括由公司生产或为公司生产的所有上市的原料药、药品以及医疗器械。
- A generic drug product is one that is comparable to an innovator drug product in dosageform, strength, route of administration, quality, performance characteristics and intended use. 仿制药在剂型,剂量,服用方式,质量,性能特征和用途方法都是和原创药物等同的。
- The nurse diluted the drug with saline water. 护士用生理盐水把药加以稀释。
- The containers shall be opened, sampled, and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures. 容器的开启、取样和重新封存须防止内容物受到污染，并且须防止污染其他的成分、药品包装，或密封件。
- Unlike a powder or liquid fill, a low fill would not be readily apparent after lyophilization particularly for a biopharmaceutical drug product where the active ingredient may be only a milligram. 不象粉末和液体灌装，冻干后的产品不能明显的发现低灌装量。特别是生物药品，它们的活性成分可能仅有几毫克。
- Since the 1930s,Thimerosal has been widely used as a preservative in a number of biologics and drug products. 自1930年以来,在许多生物制品和药品中使用硫柳汞作为防腐剂。
- The new product became a goldmine for the company. 该项新产品成了该公司的聚宝盆。
