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1、ICH Q8（中英文）blueski推荐2009-12-20出处：Julia的blog作者：不详INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE人用药物注册技术要求国际协调会议ICH Harmonised Tripartite Guideline ICH三方协调指南Pharmaceutical Development药物开发Q8Recommended for Adoption at Step 4 of the
2、ICH Process on 10 November 2005 by the ICH Steering Committee ICH指导委员会2005年11月10日ICH第四阶段推荐采用This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the f
3、inal draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 本指南根据ICH规程由合适的ICH专家工作组起草并经向法规部门咨询。在规程的第4步，建议欧洲共同体、日本和美国的药政部门采用其最终的草案。TABLE OF CONTENTS目录1. INTRODUCTION简介. 11.1 Objective of the Guideline指南目的. 11.2 Scope范围. 12. PHARMACEUTICAL DEVELOPMENT药物开发. 12.1
4、 Components of the Drug Product制剂产品的组分. 42.1.1 Drug Substance活性成分. 42.1.2 Excipients辅料. 42.2 Drug Product制剂. 52.2.1 Formulation Development配方开发. 52.2.2 Overages超量. 62.2.3 Physicochemical and Biological Properties物化和生化性质. 72.3 Manufacturing Process Development制造工艺开发. 72.4 Container Closure System容器系统
5、. 92.5 Microbiological Attributes微生物属性. 92.6 Compatibility兼容性. 103. GLOSSARY术语. 11 1. INTRODUCTION 简介1.1 Objective of Guideline 指南目的This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document
6、(CTD) format. 本指南就 CTD 格式申请文件中第3.2.P.2 章：药物开发需要叙述的内容给出了建议。 The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
7、manufacturing process. It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process
8、for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific
9、 knowledge provided. 药物开发一章给申请企业提供了一个机会，来阐述其应用科学的方法和风险管理手段，在产品及其生产工艺的开发过程中所获得的知识。它既可以被用于原始的制剂上市申请，又可以经过更新后被用于支持产品生命周期内所获得的新知识。本指导文件也说明了在什么情况下，药物和生产方面的最大程度的理解可以形成灵活的药政管理办法的基础。药物开发一章旨在为审核官和检查官就产品和生产工艺提供更详尽的理解。 1.2 Scope 范围 This guideline is intended to provide guidance on the contents of Section 3.2.P
10、.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH guideline M4). The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However, the principles in thi
11、s guideline are important to consider during those stages as well. This guideline might also be appropriate for other types of products. To determine the applicability of this guideline to a particular type of product, applicants can consult with the appropriate regulatory authorities. 本指导文件就 CTD 模块
12、3（ICH 标题 M4）中所定义的制剂的第3.2.P.2（药物开发）一章中的内容提供了指南。本指导文件不适用于临床研究阶段制剂递交文件的内容。然而，在这些阶段对本指导文件中的原则进行考虑也是重要的。本指南可能也适用于其他一些类型的产品。申请者向合适的药政管理当局进行咨询来确定本指导文件是否适用于某一特定类型的产品。 2. PHARMACEUTICAL DEVELOPMENT 药物开发 The aim of pharmaceutical development is to design a quality product and its manufacturing process to cons
13、istently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls. 药物开发的目的在于
14、设计符合质量要求的产品及符合重复生产模式的制造工艺。在药物开发和研究过程中所获得的信息和知识将为建立质量标准和生产控制提供科学的依据。 Information from pharmaceutical development studies can be a basis for quality risk management. It is important to recognize that quality cannot be tested into products; i.e., quality should be built in by design. Changes in formula
15、tion and manufacturing processes during development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space. Similarly, inclusion of relevant knowledge gained from experiments giving unexpected results can also be useful. Design space is proposed by the applicant and is subject to regulatory assessment and approval. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change
