“Pharmaceutical technology transfer consists of planned and controls actions that are based on well-defined acceptance criteria to convey a manufacturing process, analytical method, packaging component, or any other step or process along the pharmaceutical drug lifecycle from an originator site, known as a sending unit (SU), to a new site, the receiving unit (RU).”
——PDA Technical Report No. 65: Technical Transfer
（译文）药物技术转移包括基于明确定义的验收标准和控制行动，将药物的制造工艺、分析方法、包装材料或任何与生产周期相关的步骤或过程，从研发地，称为发送单位（SU）传输到新地点，接收单位（RU）

“The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.”
——ICH Q10 Pharmaceutical Quality System
（译文）技术转让活动的目的是在开发和生产之间以及生产不同场地之间进行产品和工艺知识转移，以保证产品生产的一致性，这些知识是制造工艺、控制策略、工艺验证方法和持续改造的基础。

“Quality by Design: A systematic approach to development that begins with predefined objective and emphasizes product and process understanding and process control, based on sound science and quality risk management.”
——ICH Q8 (R2) 2009
（译文）以合理的科学和质量风险管理为依据，起始于预定的质量目标，注重对产品和工艺的理解以及对生产工艺过程控制的系统的研发方法