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
Baseline Guide: Volume 6 ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities ...
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 ...
Since the first edition of this ISPE Baseline® Guide was issued in January 1999, there have been several new and revised regulatory guidance documents published by the USFDA, EMA, ICH, WHO, PIC/S and other national regulatory agencies and organizations. Some examples of changes made since th...
服务于无菌生产厂房的HVAC系统应被认为是一个可能影响患者安全和产品质量的系统。应考虑符合GEP的确认、测试和调试。 For additional information, refer toISPE Baseline® Guide:Commissioning and Qualification[34]
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 ...
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-Based Approach for the Delivery of Facilities, Systems, and Equipment ISPE指南:基于风险的设施、系统和...
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...
The ISPE GAMP Guide introduced the V Model in 1994.1In2001, the first edition of ISPE Baseline Guide, Vol. 5, commissioning andqualification (the “Commissioning and Qualification Guide”) introduced commissioning and the use of impact assessments as aformal means to identify a system’s potential...
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-Based Approach for the Delivery of Facilities, Systems, and Equipment ISPE指南:基于风险的设施、系统和...