ICHQ7a中英文对照文档格式.docx

1、5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION AND RECORDS 6. 文件和记录6.1 Documentation System andSpecifications6.1 文件系统和质量标准6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录6.3 Records of Raw Materials,Intermediates, API Labeling and PackagingMaterials6.3 原料、中间体、原料药的标签和包装材料的记录6.4 Master Produ

2、ction Instructions （MasterProduction and Control Records）6.4 生产工艺规程（主生产和控制记录）6.5 Batch Production Records （Batch6.5 批生产记录（批生产和控制记录）6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7 批生产记录审核7. MATERIALS MANAGEMENT 7. 物料管理7.1 General Controls 7.1 控制通则7.2 Receipt and Quara

3、ntine 7.2 接收和待验7.3 Sampling and Testing of IncomingProduction Materials7.3 进厂物料的取样与测试7.4 Storage 7.4 储存7.5 Re-evaluation 7.5 复验8. PRODUCTION AND IN-PROCESSCONTROLS8. 生产和过程控制8.1 Production Operations 8.1 生产操作8.2 Time Limits 8.2 时限8.3 In-process Sampling and Controls 8.3 工序取样和控制8.4 Blending Batches of

4、 Intermediates orAPIs8.4 中间体或原料药的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATIONLABELING OF APIs ANDINTERMEDIATES9. 原料药和中间体的包装和贴签9.1 General 9.1 总则9.2 Packaging Materials 9.2 包装材料9.3 Label Issuance and Control 9.3 标签发放与控制9.4 Packaging and Labeling Operations 9.4 包装和贴签操作10. STORAG

5、E AND DISTRIBUTION 10.储存和分发10.1 Warehousing Procedures 10.1 入库程序10.2 Distribution Procedures 10.2 分发程序311. LABORATORY CONTROLS 11.实验室控制11.1 General Controls 11.1 控制通则11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的测试11.3 Validation of Analytical Procedures 11.3 分析方法的验证11.4 Certificates of Analys

6、is 11.4 分析报告单11.5 Stability Monitoring of APIs 11.5 原料药的稳定性监测11.6 Expiry and Retest Dating 11.6 有效期和复验期11.7 Reserve/Retention Samples 11.7 留样12. VALIDATION 12.验证12.1 Validation Policy 12.1 验证方针12.2 Validation Documentation 12.2 验证文件12.3 Qualification 12.3 确认12.4 Approaches to Process Validation 12.4

7、 工艺验证的方法12.5 Process Validation Program 12.5 工艺验证的程序12.6 Periodic Review of Validated Systems 12.6 验证系统的定期审核12.7 Cleaning Validation 12.7 清洗验证12.8 Validation of Analytical Methods 12.8 分析方法的验证13. CHANGE CONTROL 13.变更的控制14. REJECTION AND RE-USE OFMATERIALS14.拒收和物料的再利用14.1 Rejection 14.1 拒收14.2 Reproc

8、essing 14.2 返工14.3 Reworking 14.3 重新加工14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退货15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS（INCLUDING LABORATORIES）16.协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS,DISTRIBUTORS, REPACKERS, ANDRELABELLERS17.代理商、经纪人、贸易商、经销商、重新

9、包装者和重新贴签者17.1 Applicability 17.1 适用性17.2 Traceability of Distributed APIs andIntermediates17.2 已分发的原料药和中间体的可追溯性17.3 Quality Management 17.3 质量管理17.4 Repackaging, Relabeling, and Holdingof APIs and Intermediates17.4 原料药和中间体的重新包装、重新贴签和待检417.5 Stability 17.5 稳定性17.6 Transfer of Information 17.6 信息的传达17

10、.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退货的处理18. Specific Guidance for APIsManufactured by Cell Culture/Fermentation18. 用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 18.1 总则18.2 Cell Bank Maintenance and RecordKeeping18.2 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 18.3 细胞繁

11、殖/发酵18.4 Harvesting, Isolation and Purification 18.4 收取、分离和精制18.5 Viral Removal/Inactivation steps 18.5 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 19. 用于临床研究的原料药19.1 General 19.1 总则19.2 Quality 19.2 质量19.3 Equipment and Facilities 19.3 设备和设施19.4 Control of Raw Materials 19.4 原料的控制19.5 Production

12、19.5 生产19.6 Validation 19.6 验证19.7 Changes 19.7 变更19.8 Laboratory Controls 19.8 实验室控制19.9 Documentation 19.9 文件20. Glossary 20. 术语_Q7a GMP Guidance for APIsQ7a 原料药的GMP 指南This document is intended to provide guidanceregarding good manufacturing practice （GMP）for the manufacturing of active pharmaceut

13、icalingredients （APIs） under an appropriate systemfor managing quality. It is also intended to helpensure that APIs meet the quality and puritycharacteristics that they purport, or arerepresented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。它也着眼于帮助确保原料药符合其旨在达到或表明拥有的质量与纯度要求。In

14、 this guidance, the term manufacturing isdefined to include all operations of receipt ofmaterials, production, packaging, repackaging,labeling, relabeling, quality control, release,storage and distribution of APIs and the relatedcontrols. In this guidance, the term shouldidentifies recommendations t

15、hat, whenfollowed, will ensure compliance with CGMPs.An alternative approach may be used if suchapproach satisfies the requirements of theapplicable statues. For the purposes of thisguidance, the terms current goodmanufacturing practices and goodmanufacturing practices are equivalent.本指南中所指的“制造”包括物料

16、接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和分发及其相关控制的所有操作。本指南中，“应当”一词表示希望采用的建议，除非证明其不适用或者可用一种已证明有同等或更高质量保证水平的供选物来替代。本指南中的“现行优良生产管理规范（cGMP）”和“优良生产管理规范（GMP）”是等同的。6The guidance as a whole does not cover safetyaspects for the personnel engaged inmanufacturing, nor aspects related to protectingthe environment.

17、These controls are inherentresponsibilities of the manufacturer and aregoverned by national laws.本指南在总体上未涉及生产人员的安全问题，亦不包括环保方面的内容。这方面的管理是生产者固有的责任，也是国家法律规定的。This guidance is not intended to defineregistration and/or filing requirements ormodify pharmacopoeial requirements. Thisguidance does not affect

18、 the ability of theresponsible regulatory agency to establishspecific registration/filing requirementsregarding APIs within the context ofmarketing/manufacturing authorizations or drugapplications. All commitments inregistration/filing documents should be met.本指南未规定注册/归档的要求、或修改药典的要求。本指南不影响负责药政审理部门在原

19、料药上市/制造授权或药品申请方面建立特定注册/归档要求的能力。注册/归档的所有承诺必须做到。Within the world community, materials mayvary as to their legal classification as an API.When a material is classified as an API in theregion or country in which it is manufactured orused in a drug product, it should bemanufactured according to this guid

20、ance.在世界范围内对原料药的法定定义是各不相同的。当某种物料在其制造或用于药品的地区或国家被称为原料药，就应该按照本指南进行生产。This guidance applies to the manufacture ofAPIs for use in human drug （medicinal）products. It applies to the manufacture of sterileAPIs only up to the point immediately prior tothe APIs being rendered sterile. Thesterilization and as

21、eptic processing of sterileAPIs are not covered by this guidance, butshould be performed in accordance with GMPguidances for drug （medicinal） products asdefined by local authorities.本文件适用于人用药品（医疗用品）所含原料药的生产。它适用于无菌原料药在灭菌前的步骤。本指南不包括无菌原料药的消毒和灭菌工艺，但是，应当符合地方当局所规定的药品（医疗用品）生产的GMP 指南。This guidance covers AP

22、Is that aremanufactured by chemical synthesis,extraction, cell culture/fermentation, recoveryfrom natural sources, or any combination ofthese processes. Specific guidance for APIsmanufactured by cell culture/fermentation is本文件适用于通过化学合成、提取、细胞培养/发酵，通过从自然资源回收，或通过这些工艺的结合而得到的原料药。通过细胞培养/发酵生产的原料药的特殊指南则在第18

23、 章论述。7described in Section 18.This guidance excludes all vaccines, wholecells, whole blood and plasma, blood andplasma derivatives （plasma fractionation）, andgene therapy APIs. However, it does includeAPIs that are produced using blood or plasmaas raw materials. Note that cell substrates（mammalian,

24、plant, insect or microbial cells,tissue or animal sources including transgenicanimals） and early process steps may be subjectto GMP but are not covered by this guidance. Inaddition, the guidance does not apply tomedical gases, bulk-packaged drug （medicinal）products （e.g., tablets or capsules in bulk

25、containers）, or radiopharmaceuticals.本指南不包括所有疫苗、完整细胞、全血和血浆、全血和血浆的衍生物（血浆成分）和基因治疗的原料药。但是却包括以血或血浆为原材料生产的原料药。值得注意的是细胞培养基（哺乳动物、植物、昆虫或微生物的细胞、组织或动物源包括转基因动物）和前期生产可能应遵循GMP 规范，但不包括在本指南之内。另外，本指南不适用于医用气体、散装的制剂药（例如，散装的片剂和胶囊）和放射性药物的生产。Section 19 contains guidance that only appliesto the manufacture of APIs used i

26、n theproduction of drug （medicinal） productsspecifically for clinical trials （investigationalmedicinal products）.第19 章的指南只适用于用在药品（医疗用品）生产中的原料药制造，特别是临床实验用药（研究用医疗产品）的原料药制造。An API starting material is a raw material, anintermediate, or an API that is used in theproduction of an API and that is incorpor

27、ated asa significant structural fragment into thestructure of the API. An API starting materialcan be an article of commerce, a materialpurchased from one or more suppliers undercontract or commercial agreement, or producedin-house. API starting materials normally havedefined chemical properties and structure.“原料药的起始物料”是指一种原料、中间体或原料药，用来生产一种原料药，或者以主要结构单元的形式被结合进原料药结构中。原料药的起始物料可能是在市场上有售、能够通过合同或商业协议从一个或多个供应商处购得，或由生产厂家自制。原料药的起始物料一般来说有特定的化学特性和结构。The company should designate and documentthe rationale for the point at which productionof the API begins.