需要金币:*** 金币(10金币=人民币1元) 国际制药协会ISPE基础指南05卷[归类].pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 A GUIDE FOR NEW FACILITIES VOLUME 5: COMMISSIONING AND QUALIFICATION EXECUTIVE SUMMARY JUNE 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE® GUI...
As such, this GPG does not address the design of CU systems, but serves as a companion document to these ISPE Guides (for example, ISPE Baseline® Guide: Volume 4 – Water and Steam Systems [4]). 翻译稿仅供内部学习交流使用 值得注意的是,合规性始于设计合理的系统。但是其它ISPE指南完全...
A GUIDE FOR NEW FACILITIES VOLUME 5: COMMISSIONING AND QUALIFICATION EXECUTIVE SUMMARY JUNE 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE? GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 2 ISPE BASELINE? GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 3 ISPE BASELINE? GUIDE COMMISSIONING AND...
ISPE Baseline PHARMACEUTICAL ENGINEERING Guide教材.pdf,第 1/121 页 VOLUME 1: BULK PHARMACEUTICAL CHEMICAL FACILITIES EXECUTIVE SUMMARY November 1997 VOLUME 2: ORAL SOLID DOSAGE FORMS EXECUTIVE SUMMARY OF FIRST DRAFT VOLUME 3: STERILE MANUFACTURING FACIL
Companion Volume to GAMP 5 基于风险的GXP计算机系统操作方法---GAMP 5姊妹篇 A Risk-Based Approach to Regulated Mobile Applications 基于风险的移动APP管理方法 A Risk-Based Approach to Testing of GxP Systems (Second Edition)基于风险的GXP系统检测方法（第二版）Electronic Data Archiving 电子数据归档 Globa...
(请参阅图 5。 Each type of isolator has distinct advantages and specific uses. Closed isolators tend to be highly used for lower-speed, lower- 每种类型的隔离器都有不同的优点和特定的用途。闭合隔离器往往被大量用于低速、低速 volume applications, and where containment is a concern. They are ...
LargeVolumeParenteral–maybe usedwithantibioticsandother Parenteraldrugs BasicPrinciplesofComputerizedSystemsCompliance ©2008ISPE.Allrightsreserved. Page Module1-ISPEBaselineGuide Slide11 注射类药品 注射剂需绕过人体自身对细菌和其他 微生物的防御系统。为了避免产生感 ...
Systems-ACompanionVolumetoGAMP5 GGPGOGCS/ GGPGOGCSDL $145.00$324.00$429.00 ARisked-BasedApproachtoRegulatedMobileApplications DownloadOnly GGPGMOBDL$145.00$324.00$429.00 ARisk-BasedApproachtoTestingofGxPSystems (SecondEdition) GGPGTEST2/ GGPGTEST2DL ...
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
ISPE HVAC(翻译版)国际制药工程协会对空调系统的基准指南