The other utilities covered are Pure Steam, compressed air, and compressed medical gases. CU系统是公用系统,可能会在很大程度上影响产品质量或性能。本GPG中讨论的主要CU是水系统,因为它非常复 杂且容易出现违规情况。(附录1包含特定于水系统的典型法规引用示例。)其它涵盖的公用系统包括纯蒸汽、压 缩空气和...
... 374.1 Design of Generation of Compressed Air Systems... 374.
ISPE_6.终处理选择:注射用水.pdf,ISPE Pharmaceutical Engineering Guides For New And Renovated Facilities 1 FINAL TREATMENT OPTIONS: WATER FOR INJECTION (WFI) 终处理选择:注射用水 ISPE Pharmaceutical Engineering Guides For New And Renovated Facilities 2 6.
Attachment 0 Commissioning Plan 157 Attachment P Commissioning Plan Compressed Air Supply 165 Attachment Q PM Completion Checllist 181 Attachment R Audit Template 183 Attachment S Supplier Quality Questionnaire 167 ISPE Goc:::4 PractiCe GuidEr. Good Engineering Practit~ 1 Introduction This ISPE Good ...
良好的工程质量管理 Preface 绪言 This ISPE Good Practice Guide: Good Engineering Practice (GEP) aims to provide both a definition and explanation of the term "Good Engineering Practice." The Guide covers the complete life cycle of engineering, from concept to retirement, and describes the ...
ISPE_6.终处理选择：注射用水 ISPE Pharmaceutical Engineering Guides For New And Renovated Facilities FINAL TREATMENT OPTIONS: WATER FOR INJECTION (WFI)终处理选择：注射用水 1
ispe good pr actice guide compr essed air - ISPE Good Practice Guide Compressed Air Specifications. Trace Analytics, The ISPE Good Practice Guide for Process Gases is shown below. 1 / 3 ispe launches guide to gases - cleanr oom - The ISPE Good Practice Guide: Process Gases aims to define...
有关制药用水,蒸汽以及工艺气体的指南ISPE_GPG23-Sampling.pdf,GOOD PRACTICE GUIDE: Sampling for Pharmaceutical Water, Steam, and Process Gases Disclaimer: The ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases aims to m
国际制药协会ISPE基础指南03卷.pdf,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
良好的工程质量管理 Preface 绪言 This ISPE Good Practice Guide: Good Engineering Practice (GEP) aims to provide both a definition and explanation of the term "Good Engineering Practice." The Guide covers the complete life cycle of engineering, from concept to retirement, and describes the ...