对于进厂物料，cGMP并没有强制要求进行全项检验。在评估风险和验证供应商COA后，可对某些项目进行免检，而只进行部分检验，但要求部分检验中必须包含一项鉴别检验。

§211.84组分、药品容器和密封件的检验和批准或拒绝
Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures

（d）样品应按以下方式进行检查和检验：

(d) Samples shall be examined and tested as follows:

（1）至少应进行一项检验，以确认药品中每种组分的鉴别。如果存在专一性的鉴别检验，则应使用。

(1) At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used.

（2）就每个组分的纯度、强度和质量，应进行检验，以确定是否符合所有适当的、书面化的质量标准。可以接受组分供应商提供的分析报告，代替生产商进行此类检验，但前提是生产商对此类组分进行了至少一项专一性的鉴别检验；并且生产商确立了供应商分析的可靠性，即在适当的时间间隔，对供应商的检验结果进行适当的验证。

(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）应对容器和密封件进行检验，以确保其符合所有适当的、书面化的质量标准。可以接受供应商提供的检验证书，代替生产商进行此类检验，但前提是生产商对此类容器/密封件至少进行了目视鉴别；并且生产商确立了供应商检验结果的可靠性，即在适当的时间间隔，对供应商的检验结果进行适当的验证。

(3) Containers and closures shall be tested for conformity with all appropriate written specifications. 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.