技术转移

S尘梦S

请问各位大佬：技术转移中的尽职调查指的是什么意思呢？

椒陵小小兵

你看发个出处啊，结合上下文看啊

sunguoqing

WHO 技术转移2020版
4. Due diligenceand gap assessments
尽职调查和差距评估
4.1. A process of duediligence, gap assessment or audits of the SU and RU should
be one of the firststeps when considering a technology transfer project.
在考虑技术转移项目时，首先应对转移方和接收方进行尽职调查、差距评估或审计。
4.2. The suitability and degree of preparedness of the RU should beassessed prior to the
start of the transfer. The procedure to be followedshould be documented.
接收方的适当性和准备程度应在转移开始之前进行评估。应将应遵循的程序形成文
件。
4.3. The assessment should be done by a team of appropriately qualifiedpersons with
knowledge and experience in the field of GxP and the activity tobe transferred.
评估应由一个具有 GxP 领域知识和经验的适当资质的人员组成的团队来完成。
4.4. The assessment should further cover resources including personnel,premises,
equipment and instruments, utilities, QC, documentation, computerizedsystems,
qualification and validation and waste management.
评估应进一步涵盖资源，包括人员、厂房、设备和仪器、公用设施、质量控制、文
件、计算机化系统、确认与验证以及废弃物管理。
4.5. The assessment to determine feasibility and readiness for technologytransfer may
include technical, business, regulatory and legal aspects.
确定技术转移的可行性和准备情况的评估可能包括技术、商业、监管和法律方面。

PDA TR 65
4.1.1 Project Rationale 项目合理性
Technology transfer is generally aimed at introducing innovation (e.g., a new commercial product or new productions in
existing plants) for the company, which, in turn, engages in TTPs for business opportunities.
The project rationale and project relationships (analytical/management/social) must be developed before the project
starts. The rationale defines the project plan and the relationships define the “social intelligence.” Both are fundamental
to the success of a TTP.
技术转移一般目标在于为公司引入创新（例如，新的商业化产品或厂区内新的生产线），作为回报的是商业机会。
项目的合理性和项目关联（分析/管理/社会）必须在项目开始前确定。合理性确定了项目计划，关联性确定了
社交智能。这两者是一个TTP成功的基础。