If I analyse a substance according to a Ph. Eur. monograph, do I also need to demonstrate compliance with the national monograph?
如果我按照欧洲药典各论对物质进行了分析，我还需要证明符合国家各论吗？
Do I need to validate a method that is published in the Ph. Eur. ?
我是否需要验证欧洲药典里公布的分析方法？
The authors compared the validation requirements for alternative microbiological methods between USP 1223 and Ph Eur 5.1.6 in detail.
文章详细对比了美国药典1223和欧洲药典5.1.6对于微生物替代法验证要求的异同。
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