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A GUIDE FOR NEW FACILITIES VOLUME 3: STERILE MANUFACTURING FACILITIES EXECUTIVE SUMMARY June 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE GUIDE STERILE MANUFACTURING FACILITIES JUNE 2000 2 ISPE BASELINE GUIDE STERILE MANUFACTURING FACILITIES JUNE 2000 ISPE PHARMACEUTICAL ENGINEERING GUIDE ...
Slide3 第一章学习目的 •了解ISPE基准指南的目的 •了解FDA对ISPE无菌生产设施基准指 南中的态度 •理解无菌工艺的原因 Module1-ISPEBaselineGuide Slide4 第一章学习目的 •理解无菌工艺操作的污染源 •理解美国和欧盟的GMP规范基本原则 •加强对“符合性”的认知 ...
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ISPE 基准指南(2009年上海年会)介绍 模块1 感谢 •许斌翻译 •赵春华博士校对 Basic Principles of Computerized Systems Compliance ©2008 ISPE. All rights reserved.Page
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ISPE 基准指南第7卷:基于风险管理的药品生产-第2版ISPE Baseline guide volumn 7 Risk-Based Manufacture of Pharmaceutical products-201 下载积分: 1000 内容提示: Group Facebook: EU GMP in Viet Nam 文档格式:PDF | 页数:182 | 浏览次数:993 | 上传日期:2022-11-29 15:23:42 | 文档星级: ...
3.27.技术转移(第三版)GoodPracticeGuide:TechnologyTransfer(SecondEdition) 4.基准指南BaselineGuides 4.1.卷1:活性药物成分Volume1:ActivePharmaceuticalIngredients(SecondEdition) 4.2.卷2:口服固体制剂(第三版)Volume2:OralSolidDosageForms(threeEdition) 4.3.卷3:无菌药品生产设施(第三版)Volume3:SterileProductManufac...
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