WHO 制药生产技术转移指南(2020草案)中英文对照版

WHO guidelines on the transfer of technologyin pharmaceutical manufacturing WHO制药生产技术转移指南

Background

背景

1. Introduction

介绍

2. Scope

范围

3. Glossary

术语

4. Due diligence and gap assessments

尽职调查和差距评估

5. Organization and management

组织和管理

6. Quality management and quality risk management

质量管理和质量风险管理

7. Documentation

文件

8. Premises

厂房

9. Equipment and instruments

设备和仪器

10. Qualification and validation

确认与验证

11. Product life cycle and project management principles

产品生命周期和项目管理原则

12. Phases of a technology transfer project

技术转移项目阶段

Phase I: Project initiation

阶段1：项目启动

Phase II: Project proposal

阶段2：项目计划

•Establishing a team

•建立团队

•Risk assessment

•风险评估

•Project plan

•项目计划

•Control strategy

•控制策略

Phase III: Project transfer

阶段3项目转移

•Production: transfer (processing, packaging)

•生产：转移（工艺、包装）

•Starting materials

•起始物料

•Active pharmaceutical ingredients

•活性药物成分

•Excipients

•辅料

•Information on process and finished pharmaceutical products information

•关于工艺和药物成品的信息

•Packaging

•包装

•Quality control: analytical method transfer

•质量控制：分析方法转移

•Cleaning

•清洁

Phase IV: Project review

阶段4：项目回顾

References

参考文献

Further reading

拓展阅读

Abbreviations

缩略语

Appendix 1. Example of documentation commonly required for the transferof technology

附录1. 技术转移通常需要的文件示例

Appendix 2. Example of possible experimental designs and acceptancecriteria for analytical testing

附录2. 分析测试可能的实验设计和接受标准示例

1. Introduction

介绍

1.1. Production and control procedures, validation and otherrelated activities may be transferred from one site to another site prior toobtaining a marketing authorization. In some cases, this transfer takes placeafter the approval of, for example, a product, by a regulatory authority. Thistransfer can be, for example, from drug discovery to product development; toclinical trials; or to full-scale commercialization and commercial batchmanufacturing; cleaning and validation.

在获得上市许可之前，生产和控制程序、验证和其他相关活动可能从一个场所转移到另一个查场所。在某些情况下，这种转移在产品获得监管机构的批准后也会进行。这种转移可以是，例如，从药物发现到产品开发；到临床试验；或到全面商业化和商业化批量生产；清洁和验证。

1.2. A technology transfer, particularly one between differentcompanies, has legal and economic implications. If such issues, which mayinclude intellectual property rights, royalties, pricing, conflicts of interestand confidentiality agreements, are expected to impact on the open communicationof technical matters in any way, they should therefore be addressed before andduring the planning and execution of the transfer.

技术转移，特别是不同公司之间的技术转移，具有法律和经济意义。如果这些问题(可能包括知识产权、诚信、价格、利益冲突和保密协议)预计会以任何方式影响技术事项的公开沟通，则应在转移计划和执行之前和期间予以解决。

1.3. A technology transfer requires aplanned approach by trained, knowledgeable personnel working within a qualitysystem, with documentation, data and information covering all aspects ofdevelopment, production and quality control (QC), as applicable.

技术转移需要由经过培训的具备丰富知识并在质量体系内工作的人员进行规划，并有包含所有开发、生产和质量控制（QC）（如适用）的文件记录、数据和信息。

1.4. A technology transfer takes placebetween a sending unit (SU) and a receiving unit (RU). In some cases, there maybe a separate unit managing the project.

技术转移发生在转移方（SU）和接收方（RU）之间。有时可能会有一个单独的部门来管理该项目。

1.5. The technology transfer projectshould fulfil the following general principles and requirements.