WHO第961号技术报告-附件7-药物生产技术转移指南(中英文)

WHO第961号技术报告附件7 药物生产技术转移指南（中英文1/4）

2013-09-29 14:16:27| 分类：WHO|字号订阅

World Health Organization

WHO Technical Report Series, No. 961, 2011

WHO第961号技术报告附件7 药物生产技术转移指南

Annex 7 附件7

WHO guidelines on transfer of technology in pharmaceutical

manufacturing

WHO药物生产技术转移指南

1. Introduction 介绍

2. Scope 范围

3. Glossary 术语

4. Organization and management 组织和管理

5. Production: transfer (processing, packaging and cleaning) 生产：转移（工艺、包装和清洁）

6. Quality control: analytical method transfer质量控制：分析方法转移

7. Premises and equipment 厂房设施和设备

8. Documentation 文件

9. Qualification and validation 确认和验证

References 参考文献

1. Introduction 介绍

These guiding principles on transfer of technology are intended to serve as a framework which can be applied in a flexible manner rather than as strict rigid guidance. Focus has been placed on the quality aspects, in line with WHO’s mandate.

本指南中关于技术转移的原则意在作为一个框架，以不同方式应用，而不是一个需要严格遵守的指南。指南重点在于质量方面，与WHO的任务一致。

1.1 Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, scale-up, manufacturing, production and launch, to the post-approval phase.

将工艺转移至一个可替代的场所发生在大多数产品的生命周期的某些阶段，从研发、放大、生产、到上市后阶段。

1.2 Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or

between manu facture sites”. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible and authorized party.

技术转移被定义为“控制研发方和生产方，或两个生产场所之间所有工艺关其文件和专业技术转移的逻辑程序”。技术转移是一个系统性的程序，遵守该程序是为了能将在研发过程中已记录的知识和经验转移给一个适当的，承担责任的经过授权的主体方。

Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies.

技术转移包括文件转移和接收单位的重现能力，以使用得转移技术的关键要素得以有效实施，满足参与各方和所有适用法规的要求。

1.3 Literature searches revealed little information on the subject originating from national or regional regulatory bodies. Guidance on intracompany transfers was prepared by the International Society for Pharmaceutical Engineering (ISPE) (1).

文献查阅显示来自于国家或地区药监部门关于本主题的信息非常少。ISPE（I）有一份关于跨公司转移指南。

1.4 The ever changing business strategies of pharmaceutical companies increasingly involve intra- and intercompany transfers of technology for reasons such as the need for additional capacity, relocation of operations or consolidations and mergers. The WHO Expert Committee on Specifications for Pharmaceutical Preparations, therefore, recommended in its forty second report that WHO address this issue through preparation of WHO guidelines on this matter (2).

制药企业的经营策略导致在公司间、公司内进行技术转移日益增加，原因各种各样，例如增加产能的需求、寻求新的生产场所、合并和收购。因此，WHO制剂质量标准专家委员会在WHO第42期报告中对制剂的WHO指南中阐述了对此问题的推荐。

1.5 Transfer of technology requires a documented, planned approach using trained and knowledgeable personnel working within a quality system, with documentation of data covering all aspects of development, production and quality control. Usually there is a sending unit (SU), a receiving unit and the unit managing the process, which may or may not be a separate entity. For “contract manufacturing” please see good manufacturing practices (GMP) (3).

技术转移需要一种记录的计划方式，人员应经过培训、有知识背景，在一个质量体系下工作，数据记录应覆盖研发、和平和质量控制各方面。一般会有一个转出

方(SU)，一个接收方和管理工艺的单位。管理工艺的单位可以是一个独立的主体，也可不是。关于“合同制造”，请参见GMP（3）。

1.6 For the transfer to be successful, the following general principles and requirements should be met:

为使转移成功，应符合以下一般原则和要求

the project plan should encompass the quality aspects of the

project and be based upon the principles of quality risk

management;

项目计划应基于质量风险管理，对项目的质量方面起到指导作用，

the capabilities of the SU and at the RU should be similar, but not necessarily identical, and facilities and equipment should operate

according to similar operating principles;

接收单位和转出单位的产能应相似，但不是必须的，设施和设备应根据相似的操作原则进行操作

a comprehensive technical gap analysis between the SU and RU

including technical risk assessment and potential regulatory gaps, should be performed as needed;

如有需要，应对转出单位和接收单位进行综合技术差异分析，包括技术风险评估和潜在法规差异

adequately trained staff should be available or should be trained at the RU:

接收单位应具有经过充分培训地员工，或培训其员工

—regulatory requirements in the countries of the SU and the RU, and in any countries where the product is intended to be supplied, should be taken into account and interpreted consistently

throughout any transfer programme project; and

—接收单位和转出单位的所在国法规要求，以及任何该产品将要销售的国家的法规要求，均应进行考虑，并在整个转移程序项目期间有一致的解

释

—there should be effective process and product knowledge transfer.

—工艺和产品知识转移应有效果

1.7 Technology transfer can be considered successful if there is documented evidence that the RU can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with the SU.

如果有文件化的证据证明接收单位可以正常地再次生产出所转移的产品、工艺或方法，使用其符合与转出单位协商同意的一系列既定的规格，则可以认为技术转移已经成功。

1.8 In the event that the RU identifies particular problems with the process during the transfer, the RU should communicate them back to the SU to ensure continuing knowledge management.

如果接收单位在转移过程中发现工艺有一些特别的问题，应反馈回转出单位，以保证继续进行知识管理。

1.9 Technology transfer projects, particularly those between different companies, have legal and economic implications. If such issues, which may include intellectual property rights, royalties, pricing, conflict of interest and confidentiality, are expected to impact on open communication of technical matters in any way, they should be addressed before and during planning and execution of the transfer.

技术转移项目，是那些不同公司间转移的项目，牵涉到法律和经济方面。如果这些方面，可能会包括知识产权、版税、价格、利益和保密的冲突，将会影响到技术问题的公开交流，那么在计划和实施技术转移之前和过程中应进行说明。1.10 Any lack of transparency may lead to ineffective transfer of technology.

缺乏透明度可能会导致技术转移没有效果

1.11 Some of the principles outlined in this document may also be applicable to manufacturing investigational pharmaceutical products for clinical trials as part of research and development, but this is not the

main focus of this guidance and has been excluded due to the complexity of the processes.

在本文件中列出的有些原则可能也适用于作为生产临床药品，作为研发的一部分，但这不是本指南主要关注点，并由于其过程太复杂因此未包括在其中。

1.12 Some of the responsibilities outlined in this document for the SU may also be considered to be part of the management unit responsibilities.

在本文件件中列出的转出单位的一些职责可能也可以考虑作为管理单位的职责。

2. Scope 范围

Note: This section specifically provides for transfer of quality control (QC) methods where a technical agreement exists (SU manufacturer to RU manufacturer or SU manufacturer to RU QC laboratory). Where no such technical agreements exist (e.g. testing by national laboratories or testing for procurement agencies) a number of the points listed in section 2.4 may not be workable,and alternative approaches may be required.

注：本部分特别提供给有技术协议存在时，质量控制方法的转移（转出生产方给接收生产单位生产方或转出单位生产方给接收单位QC化验室）。如果没有这样的技术协议存在（例如，由一个国家化验室进行检查，或由采购代理进行检测），在2.4部分列出的一些项可能用不上，那么可能需要替代的方法。