Technical Report No.65
PDA 2014
翻译人员名单
序号章节页码认领人
1 1.0-2.0 1-
2 334352444
2 3.0 3-11 glm1024
3 4.0-4.17 12-20 一沙一叶
4 4.2-4.
5 21-30 yan1302
5 5 31-41 开羽
6 6.0-6.2.4 42-47
lumang
7 6.3 47-56
Table of Contents 目录
1.0 Introduction 简介
2.0 Glossary of terms 术语
3.0 Technology Transfer Project 技术转移项目 4.0 Technology Transfer Process 技术转移过程
5.0 Application of Quality Risk Management to Technology Transfer 技术转移中质量风险管理的应用
6.0 Case Studies 案例分析
7.0 References 参考文献
8.0 Additional Reading 其它阅读
Figures and Tables Index 表格及索引
Figure 3.4-1 Typical Functions within a TTP
Table 3.4-1 Technologhy Transfer Organizational Components
Table 3.4.2.1-1 Responsibilities of the SU and RU
Figure 3.4.5-1 Common Flow of Information and Communication Within a Technology Transfer Team and Project
Table 5.4-1 QRM Approaches at Each Stage Gate of TTP
Table 6.1-1 Suggested AMT Responsibility Matrix
Table 6.1.2-1 General AMT Design Parameters and Considerations
Table 6.1.3-1 Examples of Method Types and AMT Performance Characteristics
Table 6.1.4-1 Typical AMT Protocol Sections
Figure 6.2.3-1 Process/Product Comparability Framework
Figure 6.3.1-1 Overall Process Mapping
Table 6.3.1-1 Example of V ariable Definitions
Table 6.3.1-2 Example of Quality Attributes Definition
Table 6.3.1-3 Severity Definition and Rating
Table 6.3.1-4 Occurance Definition and Rating
Table 6.3.1-5 Detection Definition and Rating
Table 6.3.1-6 Risk Analysis
（蒲公英论坛翻译作品）
1.0 introduction 简介
Pharmaceutical technology transfer consists of planned and controlled 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). 制药技术转移包含一些有计划的和受控的活动，这些活动根据规定好的可接受标准，从转出方
（SU ）传递生产工艺、分析方法、包装材料、或者其他任何与药品生命周期有关的步骤或者工艺到接收方（RU ）。 1.1 purpose / 目的
The purpose of this technical report is to provide guidance and best practices for conducting technology transfer activities in the pharmaceutical industry. 这篇技术报告的目的是为制药工业进行药品技术转移活动提供指南和最佳实践。
1.2 scope /范围
The report provides an overview of the knowledge and skills used during a successful technology transfer project (TTP) along with references to consult, if necessary. The report includes practical examples of technology transfer activities. Rather than discuss a particular technology transfer topic, this report aims to provide a guide to safe TTP management. 本报告提供了一个成功的技术转移项目（TTP ）使用的知识和技巧的概述，以及必要时可用的参考。本报告包括技术转移实例。不仅仅是讨论一个既定的技术转移主题，本报告也着眼于为保证的TTP 管理提供指南。
This report does not address logistics and bridging stocks, which are comprehensively discussed in
Technical Report No. 52: Guidance for Good Distribution Practices(GDPs)(1). 本报告不讨论物流和库存衔接，这个方面在第 52 号技术报告《良好分销实践指南 GDPs 》中有广泛讨论。
The technology transfer organizational elements outlined in this technical report might not be appropriate for all companies. Established practices or the availability of personnel will dictate how firms conduct technology transfer activities. 这篇技术报告中列出的技术转移组织机构可能不适用于所有公司。各公司己有的实践和人员将决定公司如何管理技术转移活动。
2.0 Glossary of Terms 术语
Failure Mode Effects Analysis (FMEA) / 失败模式影响分析（FMEA）
A tool for analyzing processes or systems to evaluate all operating steps in order to identify and assess the risk associated with any potential failures(2). 用于分析过程或系统的一个工具，通过评估所有操作
步骤来识别和评估任何潜在导致失败的风险。
Planning Bill of Materials (BOM) / 物料计划清单（BOM）
A complete list of the raw material (chemicals, media, powders, resin, etc.) and consumables/ components (filters, bags, tubing, containers, etc.) that are required to manufacture the product. 一个生产产品所需的 原料（化工品、媒介、粉末、树脂等）和耗材/组分（过滤器、袋子、管道、容器等）的完整清单。Process Flow Diagram (PFD) / 工艺流程图（PFD）
A document, typically prepared by R&D, that describes the intended manufacturing process. The PFD includes all relevant information for the operation of the manufacturing process, organized by unit operation. The PFD serves as the source document for the initial development of the master production records and is locked down once development has determined that the process can be controlled. 一个描
述计划使用的生产工艺的文件，通常由研发编写。PFD 通过单元操作来组织，包含了所有生产
工艺操作相关的信息。PFD 是初期起草主批生产记录的源文件，并且在确定工艺可控时，该文
件将被锁定。
Receiving Unit (RU) /转入方（RU）
Term for the internal or external recipient or site where the technology is being transferred to.
定义为内部或者外部接收技术的接收方或接收地。
Sending Unit (SU) /转出方（SU）
Term for the internal or external source or originator site of the technology to be transferred.
定义为内部或者外部转出技术的来源或始发地。
Work Breakdown Structure (WBS) /工作分解结构（WBS）
A hierarchical and incremental decomposition of a project into phases, deliverables, and work package
s; commonly a tree structure that shows a subdivision of effort required to achieve an objective. 将一个项
目按层级、按过程分解成阶段、可交付成果和工作包，通常是一个树状的结构展示了实现目标需
要的各级努力。
Material Safety Data Sheet (MSDS) / 物料安全数据表（MSDS）
Information provided with chemicals and other materials intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner. 提供给化工品
或其他物料的信息，用于指导工人和应急人员安全操作或使用该物质。
蒲公英论坛翻译作品
3.0 Technology Transfer Project 技术转移项目
A technology transfer procedure is more of a project than a process, as described by the Project Management Body of Knowledge (PMBOK) Guide. The guide describes a project as a defined sum of non-repetitive activities that are
designed to achieve a goal, are performed in a defined time range, employ defined resources, and are managed by a team. A process, by contrast, is the steps a given project follows (3). 根据项目管理知识指南(PMBOK)的描述，技术转移程序是一个项目而不仅仅是一个过程。该指南描述的项目是 一个各种非重复性活动的总和，这些活动是设计来实现一个目标、在规定的时间内实施、利用一定的资源、和 被一个团队管理的。一个过程，相比下，是一个特定项目按此进行的步骤。
A TTP typically provides governance for technology transfer by grouping similar activities together and moving them through each step. In this report, the technology being transferred is related directly or indirectly to a drug (small and large molecule) that is being developed or manufactured, and the manufacturing process, analytical testing, and/or other aspects of its processing and packaging are transferred either within the innovator organization or to a contract
manufacture/packager/testing facility. Preservation of the product’s quality and performance is a critical aspect of the TTP.
TTP 通常以工作归类和逐步实施的方式提供技术转移的管理。在这篇报告里，被转移的技术与药品（小分子和 大分子）的开发或生产有直接或间接的关系，生产工艺、分析方法和与加工和包装相关的其他方
面在研发机构 内部转移，或者将这些转到合同加工/包装/检测场所。保证产品的质量和性能是 TTP 的关键内容。
Technology transfer can be applied to analytical methods and partial production steps (e.g., intermediates manufacturing, a filling or packaging step, or a cleaning procedure). Technology transfer procedures can also be applied to manage the transfer of individual analytical methods or process phases (e.g., filling, packaging, or manufacturing of specific
intermediates). 技术转移可应用于分析方法和部分的生产步骤（如：中间体生产、灌装或包装步骤、或清洁程
序）。技术转移程 序也可以应用于管理个别的分析方法或者工艺阶段（如：灌装、包装、或特定中间体的生产）的转移。
The transfer of individual process steps must be supported by stability data, validation of transport of intermediates, and a gap analysis of premises and equipment. The result of this type of technology transfer is generally an increase in
manufacturing flexibility and capacity. 个别的工艺步骤转移必须有稳定性数据、中间体的运输验证、设施设备的差异分析的支持。这类转移的结果通 常是增加生产的灵活性和产能。
3.1 Technology Transfer Project Objectives / 技术转移项目目标
The objectives of TTP typically are to:
● Complete process performance qualification to demonstrate repeatability of manufacturing
● Demonstrate the similarity of the product produced at the end of the TTP at the RU
● Obtain licensing approval to manufacture and market the product
● Demonstrate robust manufacturing over a sufficiently large number of lots, including process, product, operations, and testing
● Comply with in-process intermediates and final product analytical specifications; process specifications (e.g., pH and temperature); expected yield; regulatory and quality requirements; and environment, health, and safety requirement TTP 的目标通常是：
● 完成工艺性能确认以证明生产的重复性
● 证明接收方在 TTP 的最后所生产出来的产品是相似的
● 获得生产和销售被转移产品的批文
● 通过足够多的批次，包括加工、产品、操作、和检测，证明生产的耐受性。
● 符合过程中间产物和成品质量标准，工艺标准（如，pH 和温度），期望收率，法规和质量要求，以及环境、 健康和安全要求。
A successful TTP does not guarantee zero future rejects. Rather, it provides assurance that the process and the product knowledge is fully understood and properly transferred from the SU to the
RU.
一个成功的 TTP 不能保证将来没有错误。更确切的说，TTP 为工艺和产品知识从 SU 到 RU 的充分理解和恰当 传递提供了保证。
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