WHO技术转移指引

8. DocumentationDocumentation 文件文件 8.1 The documentation required for the transfer project itself is wide ranging. Examples of documentation commonly required are summarized in Table 2. 项目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 中。 8.2 The documented evidence that the transfer of technology has been considered successful should be alized 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 at) 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) Key taskKey task 关键任务关键任务 Project definition 项目定义 技术转移文件举例（TOT） Documentation provided byDocumentation provided by Transfer Transfer SUSUdocumentationdocumentation 转出方提供的文件转出方提供的文件 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 Quality agreement 质量协议 Facility assessmentPlans and layout of facility, buildings (construction, finish) 设施评价 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 Health gap analysis 与接收单位设施、建筑 进行一一对照比较，差 异分析 Qualification protocolQualification protocol and reportand report 确认方案和报告确认方案和报告 转移文件转移文件 Project implementation plan 项目实施计划 TOT protocolTOT protocol TOTTOT 方案方案 Key taskKey task 关键任务关键任务 Analytical transfer 分析方法转移 Documentation provided byDocumentation provided by SUSU 转出方提供的文件转出方提供的文件 Analytical specification and validation, including in-process quality control 分析方法质量标准和验证， 包括中控质量控制 Transfer Transfer documentationdocumentation 转移文件转移文件 Analytical transfer protocol and report 分析方法转移方案和报 告 Starting material uation 起始物料评价 Specification and additional ination on APIs, excipients 原料药和辅料的质量标准和 额外信息 Equipment selectionInventory list of all equipment and transferand systems, including makes, models, qualification status 设备选择和转移 (IQ, OQ, PQ) 所有设备和系统清单，包括 品牌、型号、确认状态（IQ, OQ, PQ） Side-by-side comparison with RU equipment (makes, models, qualification status) 与接收单位的设备一一 对照比较（品牌、型 号、确认状态） Drawings, manuals, logs, SOPsGap analysis (e.g. set-up, operation, 差异分析 cleaning, maintenance, Qualification andQualification andcalibration, storage) validation protocol andvalidation protocol and 图纸、手册、日志、SOP reportreport （例如设定、操作、清洁、 确认和验证方案和报告确认和验证方案和报告维护、校正、存储） Process transfer: manufacturing and packaging 工艺转移生产和包 装 Reference bathes (clinical, dossier, biobatches) 参考（临床，文件，生物 批） Development report (manufacturing process rationale) 研发报告（生产工艺合理 性） History of process development at RU 接收单位工艺研发历史 Experience at RU should be recorded for future reference 接收单位的经验应记录 作为将来参考 Key taskKey task 关键任务关键任务 Documentation provided byDocumentation provided by