关于什么时候需要进行objectionable microorganisms的检测

beiwei5du

各位蒲友：

下文选自FDA cGMP,请问如果企业针对于具体产品建立了相应的objectionable microorganisms  list后，在哪些情况下需要进行相应的objectionable mcroorganisms的检测（比如放行前）呢，是每批进行检测吗？？？§211.165中的as necessary如何理解？？？

如果直接制剂企业有对具体的objectionable microorganisms进行控制，那么制剂企业是否会要求API或者原辅料企业进行相关的特定objectionable microorganisms控制呢？？你们有要求原料厂进行相关的objectionable microorganisms控制嘛？？？

§211.113   Control of microbiological contamination.

(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.

§211.165   Testing and release for distribution.

(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible.

(b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.

cnosema

按字面意思，是按需对每个批次进行检测。至于这个需，怎么定义，就得根据各自的情况了。