The pharmacy provides the drug product to the patient.
药店为患者提供药品。
Storage of released components, drug product containers, closures, and labeling;
已发放的成份、药品容器、密封件及标签的贮存。
The pharmacy orders a drug product from a specific distributor, per the manufacturer.
药店从特定的分发商处订购药品。
These additives and other small molecules, may leach into the drug product over time.
这些添加剂和其它一些小分子，可能会随着时间的推移而析出到药品中。
The submitted drug product samples should be from a batch made with the proposed market formulation.
所递交的制剂样品必须是根据拟定的上市配方生产的。
A written record of each complaint shall be maintained in a file designated for drug product complaints.
每个投诉的文字记录保存在药品专用档案内。
Photostability testing should be conducted on at least one primary batch of the drug product if appropriate.
如可能，光稳定性试验至少应在一个起始批上进行。
The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.
强降解试验的性质取决于单个原料药和涉及的制剂的类别。
It has been demonstrated that impurities in a finished drug product can cause degradation and lead to stability problems.
证明杂质在最后的制剂中可能会引起降解，并导致稳定性有问题。
According to 21 CFR 210.3 (b) (8), an inactive ingredient is any component of a drug product other than the active ingredient.
根据21cfr 210.3 (b)(8)，非活性成分是制剂中除了活性成分以外的任何成分。
Moreover, CGMPs require written procedures for evaluating the quality standards of each drug product at least annually (211.180).
此外，cGMP还要求按照书面程序对每个药品的质量标准每年至少评估一次。
It is possible for a drug product to travel through a network of four to eight (or more) distributors before it gets to a pharmacy.
在药品到达药店之前，它可能经历4至8个(或者更多)分发商。
Particle size distribution and surface area of the drug substance may affect the dissolution and bioavailability of the drug product.
原料药的粒度分布和表面面积可能会影响药品的溶出度与生物利用度。
Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue.
刊登这一信息并不代表FDA已经认为该药品与所述的安全性问题有因果关系。
Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.
药品容器的包装袋或包装箱或密封件应离地面放置保持适当间隔，全球清洁和检查。
The importance of the toxicological risk assessment is to ensure that these leachables do not adversely affect the stability or efficacy of the drug product.
毒理学风险评估的重要性是为了确保这些浸出物不会对药品的稳定性和有效性产生负面影响。
In the case of quantitative analysis of impurities accuracy should be assessed on samples (of drug substance or drug product) spiked with known amount of impurities.
对于杂质的定量分析，应使用以已知数量杂质增敏的样榀来评估准确度。
Methods Providing the inspiration for OTC drug research and work through brief introduction the research and the relevant advice on adolescent OTC drug product use in the United States.
方法通过简述美国青少年非处方药品使用研究及其相关建议，提出对我国非处方药相关工作与研究的启示。
If an excipient manufacturer states that class 2 solvents are present in their excipient, but below the option 1 limit, does the drug product manufacturer have to test for these solvents?
如果辅料生产商声明其辅料中存在2类溶剂，但低于选项1限度，制剂生产商是否必须测试其溶剂？
Pharmaceutical equipment and high purity water systems are designed so that product contact surfaces are not reactive, additive, or absorptive so the drug product is not adversely altered.
为了使得药品没有不利变化，在设计制药设备和高纯水系统时，保证它们和产品的接触面是不具有反应性、添加性和吸收性的。
Pharmaceutical equipment and high purity water systems are designed so that product contact surfaces are not reactive, additive, or absorptive so the drug product is not adversely altered.
为了使得药品没有不利变化，在设计制药设备和高纯水系统时，保证它们和产品的接触面是不具有反应性、添加性和吸收性的。
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