ISPE技术指南
针对制药生产各热点议题提供最佳解决方案和建议,对规章制度提出解释。
ISPE 技术指南分为基准指南系列、良好自动化生产实践指南系列和良好实践指南系列。
此外,ISPE中国还对四本技术指南进行了汉化,分别为《无菌生产设施(第二版)》;GAMP® 5 ;《固体口服制剂(第二版)》;《制造执行系统-战略和项目管理方法》
针对制药生产各热点议题提供最佳解决方案和建议,对规章制度提出解释。
ISPE 技术指南分为基准指南系列、良好自动化生产实践指南系列和良好实践指南系列。
此外,ISPE中国还对四本技术指南进行了汉化,分别为《无菌生产设施(第二版)》;GAMP® 5 ;《固体口服制剂(第二版)》;《制造执行系统-战略和项目管理方法》
Guidance Document Translations Available —Chinese
Please contact China@ispe.org for more details or to order these guides.
The following titles are available as bound copies unless otherwise specified.
Baseline® Guide: Oral Solid Dosage Forms (Second Edition)
Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition)
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)
GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach (MES) (First Edition) - available as electronic only
Please contact China@ispe.org for more details or to order these guides.
The following titles are available as bound copies unless otherwise specified.
Baseline® Guide: Oral Solid Dosage Forms (Second Edition)
Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition)
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)
GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach (MES) (First Edition) - available as electronic only
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