成人午夜又粗又硬又长_鲁一鲁AV2019在线_欧美深深色噜噜狠狠yyy_www.91色.com_色影音先锋av资源网_特级做A爰片久久毛片A片喷水_99精品无人区乱码1区2区3区_国产人妻久久精品一区_欧美午夜精品久久久久久浪潮_av免费无码天堂在线_蜜桃色欲AV久久无码精品软件_日美一级毛片_久久久久久久久性潮_国产乱对白精彩_日韩精品免费一区二区_亚洲欧美精品在线_无码国产69精品久久久久_开心五月综合激情综合五月_干一夜综合_亚洲中文有码字幕日本

對于進廠物料，cGMP并沒有強制要求進行全項檢驗。在評估風險和驗證供應商COA后，可對某些項目進行免檢，而只進行部分檢驗，但要求部分檢驗中必須包含一項鑒別檢驗。

§211.84組分、藥品容器和密封件的檢驗和批準或拒絕
Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures

（d）樣品應按以下方式進行檢查和檢驗：

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

（1）至少應進行一項檢驗，以確認藥品中每種組分的鑒別。如果存在專一性的鑒別檢驗，則應使用。

(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）就每個組分的純度、強度和質量，應進行檢驗，以確定是否符合所有適當的、書面化的質量標準。可以接受組分供應商提供的分析報告，代替生產商進行此類檢驗，但前提是生產商對此類組分進行了至少一項專一性的鑒別檢驗；并且生產商確立了供應商分析的可靠性，即在適當的時間間隔，對供應商的檢驗結果進行適當的驗證。

(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）應對容器和密封件進行檢驗，以確保其符合所有適當的、書面化的質量標準。可以接受供應商提供的檢驗證書，代替生產商進行此類檢驗，但前提是生產商對此類容器/密封件至少進行了目視鑒別；并且生產商確立了供應商檢驗結果的可靠性，即在適當的時間間隔，對供應商的檢驗結果進行適當的驗證。

(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.