WHO技术转移指南.docVIP

Documentation 文件 The documentation required for the transfer project itself is wide ranging. Examples of documentation commonly required are summarized in Table 2. 项iq转移本身文件要求范围很宽。常规要求的文件举例归纳在表2屮。 The documented evidence that the transfer of technology has been considered successful should be formalized and stated in a technology transfer summary report. That report should summarize the scope of the transfer，the critical parameters as obtained in the SU and RU (preferably in a tabulated format) and the final conclusions of the transfer. Possible discrepancies should be listed and appropriate actions，where needed，taken to resolve them. 一个技术转移被认为是成功的时候，证明其成功的文件证据需要正式化，并在技 术转移总结报告中申明。该报告应总结转移的范围、转出单位和接收单位所获得 的关键参数(最好以表格形式)、转移的最终结论。应列出可能的差异，如果需 要时，应采取可能的措施解决并记录。 Table 2 表 2 Examples of documentation for transfer of technology （TOT） 技术转移文件举例（TOT） Key task 关键任务 Documentation provided by su 转出方提供的文件 Transfer documentation 转移文件 Project definition 项目定义 Project plan and quality plan （where separate documents）， protocol, risk assessments，gap analysis 项目计划和质量计划（如果文 件分开），方案、风险评估、 差异分析 Project implementation plan 项目实施计划 TOT protocol TOT方案 Quality agreement 质量协议 Facility assessment 设施评价 Plans and layout of facility, buildings （construction，finish） 设施和厂房的平面图（建筑、 处理方法） Qualification status （DQ，IQ， OQ） and reports 确认状态（DQ,IQ，OQ）和报 告 Side-by-side comparison with RU facility and buildings; gap analysis 与接收单位设施、建筑进 行一一对照比较，差异分 析 Qualification protocol and report 确认方案和报告 Health Safety assessment 卫生和安全评价 Product-specific waste management plans 产品专用废物管理计划 Contingency plans 应急方案 Skill set analysis and training 熟练程度分析和培 训 SOPs and training documentation （product-specific operations，analysis, testing） SOP和培训文件（产品专用操 作、分析检测） Training protocols， assessment results 培训方案，评价和结果 Analytical method Analytical method specification Analytical method transfer  Key task 关键任务 Documentation provided by SV 转出方提供的文件 Transfer documentation 转移文件 transfer 分析方法转移 and validation，including in-process quality co