WHO第961号技术报告_附件7_药物生产技术转移指南(中英文)讲义.docx

WHO第961号技术报告 附件7 药物生产技术转移指南World Health OrganizationWHO Technical Report Series, No. 961, 2011WHO第961号技术报告附件7 药物生产技术转移指南?Annex 7?附件7WHO guidelines on transfer of technology in pharmaceutical manufacturingWHO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 during development and or commercialization to an appropriate, responsible and authorized party.技术转移被定义为“控制研发方和生产方，或两个生产场所之间所有工艺文件和专业技术转移的逻辑程序”。技术转移是一个系统性的程序，遵守该程序是为了能将在研发过程中已记录的知识和经验转移给一个适当的，承担责任的经过授权的主体方。Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies.技术转移包括文件转移和接收单位的重现能力，以使用得转移技术的关键要素得以有效实施，满足参与各方和所有适用法规的要求。1.3 Literature sear