Guideline for Technology Transfer (Draft)
技术转移指南（草案）
Introduction
绪论
This research is intended to indicate appropriate guidance for technology transfer expected to increase under the new manufacturing and marketing approval system to be implemented by the revised Japanese Pharmaceutical Affairs Law, and supplement the GMP regulations to be revised soon. The research is also intended to propose some regulations to realize technology transfer necessary for high quality and stable manufacturing of developed products and existing products by reviewing technology transfer based on the following ideas.
本研究旨在注明技术转移的相关指南，在新的制造和市场评估体系下，期望增加这些指南被修改后的日本药事法规和随后马上修改的GMP法规执行。本指南通过审核技术转移，基于如下观点，另一旨意是拟订一些法规，从而实现技术转移，确保新开发产品和已存在产品的高质量和能持续产出。
The technology transfer means actions to transfer information and technologies necessary to realize quality of design of drugs during manufacturing.
技术转移意味着转移必要的资料和技术以实现生产中药品能达到设计的要求
Appropriate technology transfer is important to upgrade the quality of design to be the quality of product, and ensure stable and high quality of the product.
合理的技术转移对提高设计质量成为产品质量很重要，并确保产品的持续生产出和较高质量
It should be noted that drugs may influence human lives and health, and their raw materials, compositions and manufacturing methods are changed during their long term manufacturing and marketing.
应该注意的是药品会影响人类的生命和健康，其原辅料，组成以及制造方法在长期的生产和上市中会有变化。
To assure the drug quality, it is desired to make sure 5 W’s and 1 H, that is what, when and why information should be transferred to where and by whom and how to transfer, then share knowledge and information of the drug product between transferring and transferred parties.
为了确保药品的质量，要确保5个W和一个H. 那就是，什么，何时，为什么资料要倍何人转移到哪里去，怎样转移，然后是在转移方和接受方分享产品的知识和信息。
The technology transfer does not mean one time actions taken by the transferring party toward the transferred party, but means continuous information exchange between the both parties to maintain the product manufacturing.
技术转移并不意味着就是由转移方向向接受方的一次性措施，而是在双方之间持续的信息交换来维护产品的生产。
Basic Policies on the Establishment of the Guideline for the Technology Transfer
技术转移指南建立的基本方针
The basic policies on the establishment of this guideline are shown as follows.
本指南建立的基本方针如下，
Assurance of consistency through development and manufacturing
从开发到生产持续地保证
To make developed product have indications as assumed in clinical phases, the quality of design should be reproducible as the quality of product.
使得开发的产品有临床阶段假定的适应症，涉及的质量应能和产品的质量重现。
The transferring party in charge of development should fully understand what kind of technical information is required for the technology transfer, and should establish an appropriate evaluation method to determine whether a drug to be manufactured meets the quality of design.
负责开发的转移方应完全理解技术转移中需要什么类型的技术资料，并应建立一个评估方法以确定是否待生产药品会符合设计的质量
It should be fully recognized that technical information of developed product are generated from data of a limited amount of batches, various standards have been established from the limited data, and quality evaluation method established in development phase is not always sufficient for factory production. Information of similar products of the past should be fully referred as well.
需要充分意识到开发产品的技术资料是从有限量的批次中获得的数据，从有限的数据中建立了不同的标准，在开发阶段建立的质量评估方法并不总能足够适用于工厂生产。以前相似产品的资料也应充分参考。
Embodiment of Quality by Specifications
通过质量标准控制的质量控制具体方案
It is desired to verify that the specification adequately specifies the product properties and quality.
需要确认质量标准准确地指明了产品的性质和质量
The product specification should ensure that the quality assumed in the quality design is assured as the manufacturing quality, and the product satisfies the quality of design.
产品质量标准应确保质量设计中假定的质量可以确保为生产质量，并且产品满足设计的质量
It should be fully understood that manufacturing quality is based on the product specification. Relations between control limits of manufacturing formula (compositions and manufacturing methods) and limits of the product specification should be fully understood, and appropriate specifications and the control range should be established to maintain the consistency between the manufacturing quality and product specification.
需要充分理解制造质量应基于产品的标准。制造公式（组分和制造方法）和产品质量标准的关系应充分理解，应建立合理的质量标准和控制范围以维持生产质量和产品标准间的一致性。
For specifications of raw materials, components, intermediates, and in process testing, consistency between test items, specification range, and product specifications should be maintained.
对于原辅料，组分，中间体和中控检测的质量标准，应维持检测项目，标准范围和产品标准的一致性。
Since initial manufacturing formula and specification are established based on limited information, the consistency between the quality and specification after the start of manufacturing should be fully verified, and these should be revised through appropriate change controls, if necessary.
因为起初的制造方式和标准的建立是基于有限的资料，在制造开始后质量和标准的连续性应充分确认，必要地话通过合理的变更控制来修改。
Documentation Management and Update of Technical Information
文件管理和技术资料
Responsibility system should be established in view of accountability (responsibility for giving sufficient information) and responsibility (responsibility for consequences of actions). For that purpose, appropriate documentation management of technology transfer is highly desired.
鉴于提供充分资料职责和措施结果职责，应建立责任制。对于此目的，强烈要求技术转移的合适的文件管理。
For drugs as they have long product shelf life, the documentation management should be performed assuming that the technology transfer would occur several decades after the completion of development.
对于有较长有效期的药品，文件管理应进行，要考虑技术转移可能在开发完成后几十年后发生。
Initial manufacturing quality is established based on limited information. As a result, it may be necessary to propose revised technical information at regular intervals as additional information of the product quality is gained and accumulated with improvements or revisions of specifications and test methods.
起初的生产质量的建立是基于有限的资料。结果，可能很有必要定期拟订修改技术资料，因为额外的产品质量的资料获得和积累，质量标准和检测方法的提高或改进
Table of Contents
目录表
The table of contents is shown as follows. The 1st chapter addresses background and the scope of the guideline. The 2nd chapter addresses handling and contents of technologies to be transferred at each process from research and development to manufacturing. The remaining chapters address procedures, documentation, and points of concern with regard to facilities, test methods, drug substances, and drug products all of which are closely involved with drug manufacturing.
目录表如下，第1章节叙述了指南的背景和范围。第二章叙述了从每个研发和开发阶段想制造的转移技术的处理和内容。剩下的章节叙述了和厂房，检测方法，原料药和制剂相关的方法，文件，和相关点，这些都和药品生产紧密相关。
1. Preface
序言
1.1 Background
背景
1.2 Objective
目的
1.3 Scope
范围
1.4 Organization
组织
2. Technology Transfer Process
技术转移过程
2.1 Quality Design (Research Phase)
质量设计（研发阶段）
2.2 Scale-up and Detection of Quality Variability Factors (Development Phase)
放大规模和质量可变因素的测定（开发阶段）
2.2.1 Research for Factory Production
工厂生产调研
2.2.2 Consistency between Quality and Specification
质量和标准的连续性
2.2.3 Assurance of consistency through development and manufacturing
从开发到生产的保证
2.3 Technology Transfer from R&D to Production
从研发到生产的技术转移
2.4 Validation and Production (Production Phase)
验证和生产（生产阶段）
2.5 Feedback of Information Generated from Production Phase and Technology Transfer of Marketed Products
从生产阶段产生资料
3. Procedures and Documentation of Technology Transfer
技术转移的方法和文件
3.1 Organization for Technology Transfer
技术转移的机构
3.2 Research and Development Report
调研和开发报告
3.3 Technology Transfer Documentation
技术转移文件
3.3.1 Product Specification (Product Specification File)
产品标准（产品标准文件）
3.3.2 Technology Transfer Plan
技术转移计划
3.3.3 Technology Transfer Report
技术转移报告
3.3.4 Check and Approval by Quality Assurance Department
质量保证部的确定和批准
3.4 For Implementation of Technology Transfer
技术转移的执行
3.5 Manufacturing Related Documents Including Drug Product Standards
生产相关的文件包括产品标准
3.6 Verification of Results of Technology Transfer
技术转移结果的确认
3.7 Points of Concern for Post-Marketing Technology Transfer
上市后技术转移相关要点
4. Examples of Technical Information to be Contained in Technology Transfer
Documentation
包含在技术转移文件中的技术资料的例子
4.1. Technical Information of Facilities and Equipments
厂房和设备的技术资料
4.1.1 Technical Information to Establish New Facilities and Equipments
建立新厂房和设备的技术资料
4.1.2 Technical Information When Applied to Established Facilities and Equipments
用于已建立厂房和设备的技术资料
4.2 Technology Transfer of Test Methods
分析方法的技术转移
4.2.1 Development Report of Test Methods
检测方法的开发报告
4.2.2 Technology Transfer Plan
技术转移计划
4.3 Technology Transfer of Drug Substances
原料药技术转移
4.3.1 Information to be Collected During Quality Design (Research Phase)
在质量设计中收集的资料（研发阶段）
4.3.2 Items to be Checked in the Review of Scale-up
放大中核查项目
4.3.3 Elucidation of Quality Variability Factors
质量可变因素的阐明
4.3.4 Development Report on Synthetic Drug Substances
合成原料药的开发报告
4.3.5 Technology Transfer of Synthetic Drug Substances from R&D Department to
Manufacturing Department
从研发部到生产部合成原料药的技术转移
4.4 Technology Transfer of Drug Products
制剂技术转移
4.4.1 Information to be Collected During Quality Design (Research Phase)
质量设计中收集的资料(调研阶段)
4.4.2 Scale-up Validation and Detection of Quality Variability Factors (Development
Phase)
规模放大验证和质量可变因素的检测(开发阶段)
4.4.3 Development Report
开发报告
4.4.4 Information of Technology Transfer of Drug Products
制剂技术转移资料
5. Points of Concern For Preparing Technology Transfer Documentation
准备技术转移文件相关要点
5.1 Documents To Clarify Applicable Technologies, Burden Shares and Responsibility
System, etc. Concerning Technology Transfer
澄清关于技术转移的可用技术的文件,负担分担和责任系统,等
5.2 Technical information to be Described in the Development Report, and Product
Specification, etc.
开发报告和产品质量标准中要叙述的技术资料,等.
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发表于 2014-5-6 06:50:10
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