water run particle run engineering run 是哪个指南提到的

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water run           particle run               engineering run


这三个流程是从哪个法规或指南上引用的？

JIANG12345

接个楼学一下

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DXH1526

在ISPE《GOOD PRACTICE GUIDE Technology Transfer (Third Edition) 》中提到：
water run：
3.4  Operational Readiness
“……Testing of full scale manufacturing equipment to ensure proper function, e.g., mixing studies, buffer or water runs,cleaning studies, etc.”

Engineering run：
5.2.4 At Scale Process (Procedure) Evaluation and Qualification
“…… Engineering runs are defined here as trial full scale runs performed in the same equipment to be used for GMPmanufacturing using the intended procedures and without the intent to be released for use. ……”

有用的话，请点“药学专业认可”小红星

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DXH1526 发表于 2023-2-28 15:59
在ISPE《GOOD PRACTICE GUIDE Technology Transfer (Third Edition) 》中提到：
water run：
3.4  Operat ...

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