注:附录1列有技术转移通常需要的文件示例。

7.1. An authorized technology transfer document should list theintended sequential phases and activities of the transfer. The document shouldinclude, for example, the following:

应有经批准的技术转移文件列出转移的预定阶段和活动。例如，该文件应包括下列内容:

• title;

• 标题

• objective;

• 目的

• scope;

• 范围

• name and addresses of the SU and RU;

• 转移方和接收方的名称和地址

• names of key personnel and theirresponsibilities;

• 关键人员的名字及其职责

• phases of the project and actions;

• 项目的阶段和活动

• a parallel comparison of premises,equipment, instruments, materials, procedures, and methods;

• 对厂房、设备、仪器、物料、程序和方法的平行比较

• experimental design, quality attributes,process parameters and acceptance criteria;

• 实验设计、质量属性、工艺参数和接受标准;

• information on trial production batches,qualification batches and process validation;

• 有关试产批、确认批和工艺验证的信息;

• change and deviation management;

• 变更和偏差管理

• arrangements for keeping retention samplesof active ingredients, intermediates and finished products, and information onreference substances where applicable; and

• 活性成分、中间体和成品留样的保存，以及有关对照物质的信息(如适用);和

• review of the transfer, outcome, signature(s)and date of conclusion of the transfer.

• 转移、结果、转移结论签字/日期的审核。