A GUIDE FOR NEW FACILITIES VOLUME 6: BIOPHARMACEUTICALS EXECUTIVE SUMMARY OF DRAFT FOR REVIEW JANUARY 2003 1-1 Copyright: This document is owned by ISPE. No reproduction of the whole or any part of this document is to be made without the written authority of ISPE. 1-2 ISPE BASELINE GUIDE ...
免费在线预览全文 A GUIDE FOR NEW FACILITIES VOLUME 6: BIOPHARMACEUTICALS EXECUTIVE SUMMARY OF DRAFT FOR REVIEW JANUARY 2003 1-1 Copyright: This document is owned by ISPE. No reproduction of the whole or any part of this document is to be made without the written authority of ISPE. 1-2 ...
VOLUME 6: BIOPHARMACEUTICALS JANUARY 2003 EXECUTIVE SUMMARY OF DRAFT FOR REVIEW 第 2/121 页 A GUIDE FOR NEW FACILITIES VOLUME 1: BULK PHARMACEUTICAL CHEMICAL FACILITIES EXECUTIVE SUMMARY November 1 1997 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: 第 3/121 页 ISPE Baseline Guide - Bulk Pharmaceutical ...
ISPE基准指南:调试和确认(第二版)取代以下指南: ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (First Edition) ISPE基准指南:第5卷-调试和确认(第一版) ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment ISPE指南:基于科学和风险方法...
system leakage through pressure testing and level monitoring.The location of the heat transfer medium piping should be carefully consideredto not impede on the aseptic processing areas if a leak occurs. For furtherinformation, refer toISPE Baseline® Guide: Water and Steam Systems (SecondEdition)[...
Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition) 卷6:生物药品生产设施(第二版) Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) 卷7:基于风险的药品生产(风险MAPP) Baseline Guides Under Development 制订中的基准指南 ISPE Guides ISPE Guide: Science and Risk-Base...
as a companion document to these ISPE Guides (for example, ISPE Baseline® Guide: Volume 4...
Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition) 卷6:生物药品生产设施(第二版) Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) 卷7:基于风险的药品生产(风险MAPP) Baseline Guides Under Development 制订中的基准指南 ISPE Guides ISPE Guide: Science and Risk-Base...
Ispe Baseline Guide:Volume 5-Commissioning And Qualification(First Edition) Ispe Guide:Science And Risk-Based Approach For The Delivery Of Facilities,Systems,And Equipment Ispe Good Practice Guide:Applied Risk Management For Commission And Qualification ...
Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition)? 卷6:生物药品生产设施(第二版)? Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk- 7、MaPP)? 卷7:基于风险的药品生产(风险 MAPP )? Baseline Guides Under Development?制订中的基准指南ISPE Guides? ISPE Guide: Science...