WHO第961号技术报告附件7药物生产技术转移指南(中英文)VIP专享VIP免费

WHO 第 961 号 技 术 报 告 附 件 7 药 物 生 产 技 术转 移 指 南 （ 中英文 1/4） 2013-09-29 14:16:27| 分类： WHO|字号 订阅 World Health Organization WHO Technical Report Series, No. 961, 2011 WHO 第961 号技术报告 附件7 药物生产技术转移指南 Annex 7 附件7 WHO guidelines on transfer of technology in pharmaceutical manufacturing WHO 药物生产技术转移指南 1. Introduction 介绍 2. Scope 范围 3. Glossary 术语 4. Organization and management 组织和管理 5. Production: transfer (processing, packaging and cleaning) 生产：转移（工艺、包装和清洁） 6. Quality control: analytical method transfer 质量控制：分析方法转移 7. Premises and equipment 厂房设施和设备 8. Documentation 文件 9. Qualification and validation 确认和验证 References 参考文献 1. Introduction 介绍 These guiding principles on transfer of technology are intended to serve as a framework which can be applied in a flexible manner rather than as strict rigid guidance. Focus has been placed on the quality aspects, in line with WHO’s mandate. 本指南中关于技术转移的原则意在作为一个框架，以不同方式应用，而不是一个需要严格遵守的指南。指南重点在于质量方面，与WHO 的任务一致。 1.1 Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, scale-up, manufacturing, production and launch, to the post-approval phase. 将工艺转移至一个可替代的场所发生在大多数产品的生命周期的某些阶段，从研发、放大、生产、到上市后阶段。 1.2 Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained ...