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
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 ...
因此,受监管的公司和服务提供商应积极主动,了解行业发生的变化和当前的最佳实践。 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 nation...
For example, if compressed air is used to operate avial filler and the pressure of the air dictates the line speed (independent offill volume), then due consideration should be given to a substantivequalification regime with high and low pressure alarms for the service. 例如,如果使用压缩空气进...
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
ISPE Baseline?Pharmaceutical Engineering Guides for New and Renovated Facilities ISPE基准:新设施和创新型设施药品工程指南 Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals 卷1:活性药物成分(第二版)---对散装药用化学品的修订 Volume 2: Oral Solid Dosag...
感谢共享，准确的说应该是 ISPE Baseline Volume4 ：Water and Steam System。
as a companion document to these ISPE Guides (for example, ISPE Baseline® Guide: Volume 4...
ISPE Baseline?Pharmaceutical Engineering Guides for New and Renovated Facilities ISPE基准:新设施和创新型设施药品工程指南 Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals 卷1:活性药物成分(第二版)---对散装药用化学品的修订 Volume 2: Oral Solid Dosag...
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...