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WHO发布《制药生产技术转移指南》!
来源: | 作者:4SHQ | 发布时间: 256天前 | 4535 次浏览 | 分享到:

转移方应提供与所转移的工艺、产品或程序有关的必要文件。

 

5.5. The SU should provide criteria and information on inherentrisks, hazards and critical steps associated with the process, product orprocedure to be transferred. This may serve as a basis for the risk assessmentexercise.

转移方应提供与所转移的工艺、产品或程序相关的固有风险、危害和关键步骤的标准和信息。这可作为风险评估工作的基础。

 

5.6. The technology transfer should be managed by responsiblepersons from the SU and RU. A technology transfer team may be appointed withidentified and documented responsibilities.

技术转让应由转移方和接收方的负责人管理。可以任命一个技术转移小组,其职责应明确并形成文件。

 

5.7. The team members should have the necessary qualifications andexperience to manage the particular aspects of the transfer.

团队成员应该具备必要的资质和经验来管理转移的特定方面。

 

5.8. The SU should make all the necessary information and knowledgewith regard to the product, process or procedure available in relevantdocuments in order to ensure a successful transfer.

转移方应在相关文件中提供与产品、工艺或程序有关的所有必要信息和知识,以确保成功的转移。

 

5.9. A training programme should be implemented specific to theprocess, product or procedure to be transferred.