21CFR211 有一处英文不明白

Chenging

211.84 testing and approval or rejection of components, drug product containers, and closure
(2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
(3) Containers and closures shall be tested for conformance with all appropriate written procedures. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals.
为什么这里用的词都不一样呢，不都是COA吗？

zhangj4h

不太一样，COA （Certificate of Analysis）检验报告书是较官方的一份证书，其内容包括生产厂家信息，产品信息，检验信息。分析报告（Analysis Report）较为简单，可能只有简单的产品信息和检验数据。

myreebok

有关系么。。。爸爸也是亲爹啊

cnosema

用词习惯性吧，没什么区别

cts9166

就是路过，看看

zhangj4h

Customers and regulators rely on CoA for information about the quality and sourcing of drugs and their components. Omitting information from CoA compromises supply-chain accountability and traceability, and may put consumers at risk.
这句话来自FDA对苏州制药技术有限公司警告信，可见对于COA，需要显示很多信息的！

beiwei5du

可能对于component这类的使用analysis（检测分析），而针对于container and closure类的使用testing（测试）比较合适吧。