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。
Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated.
允许使用其他方法(包括自动化方法)进行检测，但必须证明这些方法与药典方法相比同样适用。
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