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1、Annex 2WHO good manufacturing practices for pharmaceutical products: main principles附录2WHO药品GMP：主要原则Introduction引言General considerations总则Glossary术语Quality management in the medicines industry: philosophy and essential elements制药企业的质量管理：GMP理念和基本元素1. Pharmaceutical quality system 制药质量体系Quality risk m
2、anagement 质量风险管理新增Product quality review 产品质量回顾2. Good manufacturing practices for pharmaceutical products 药品GMP3. Sanitation and hygiene 清洁和卫生4. Qualification and validation 确认和验证5. Complaints 投诉6. Product recalls 产品召回7. Contract production, analysis and other activities 委托生产、检验和其他活动修改General 概述The
3、 contract giver 委托方The contract accepter 被委托方The contract 合同8. Self-inspection, quality audits and suppliers audits and approval 自检、质量审计、供应商审计和批准Items for self-inspection 自检项目Self-inspection team 自检团队Frequency of self-inspection 自检频率Self-inspection report 自检报告Follow-up action 后续措施Quality audit 质量审计S
4、uppliers audits and approval 供应商审计和批准9. Personnel 人员General 概述Key personnel 关键人员10. Training 培训11. Personal hygiene 人员卫生12. Premises 厂房General 概述Ancillary areas 辅助区域Storage areas 仓储区域Weighing areas 称量区域Production areas 生产区域Quality control areas QC区域13. Equipment 设备14. Materials 物料General 概述Starting
5、materials 起始物料Packaging materials 包装材料Intermediate and bulk products 中间体和成品Finished products 制剂Rejected, recovered, reprocessed and reworked materials 不合格、回收、返工和重加工物料Recalled products 召回产品Returned goods 退货Reagents and culture media 试剂和培养基Reference standards 标准品Waste materials 废弃物料Miscellaneous 其他15.
6、 Documentation 文件General 概述Documents required 需要的文件16. Good practices in production 生产良好规范General 概述Prevention of cross-contamination and bacterial contamination during production生产过程中交叉污染和额细菌污染的预防Processing operations 生产操作Packaging operations 包装操作17. Good practices in quality control QC良好规范Control
7、of starting materials and intermediate, bulk and finished products 原材料、关键中间体、原料药和制剂的控制Test requirements 检测要求Batch record review 批记录审核Stability studies 稳定性研究References 参考文献Introduction引言The first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at th
8、e request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-first World Health Assembly under the title “Draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialities” and
9、 was accepted.应第二十届世界卫生大会（大会决议WHA20.34）的要求，1967年由一顾问小组起草了WHO首版GMP草案。随后，以“药品和药学类的生产和质量控制的GMP草案要求”为题提交到第二十一届世界卫生大会并通过。The revised text was discussed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1968 and published as an annex to its twenty-second report. The text was
10、 then reproduced (with some revisions) in 1971 in the Supplement to the second edition of “The International Pharmacopoeia”.1968年，WHO药品规范专家委员对修订的版本进行了讨论，并将其作为该委员会第22次报告附录出版。1971年，文档被复制后（有一些修订）作为国际药典第二版的补充内容出现。In 1969, when the World Health Assembly recommended the first version of the WHO Certificat
11、ion Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in resolution WHA22.50, it accepted at the same time the GMP text as an integral part of the Scheme. Revised versions of both the Certification Scheme and the GMP text were adopted in 1975 by resolution WHA28.65. S
12、ince then, the Certification Scheme has been extended to include the certification of: veterinary products administered to food-producing animals; starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting Member State and the importing Member S
13、tate; information on safety and efficacy (resolution WHA41.18, 1988).1969年，世界卫生大会在大会决议（WHA22.50）中形成第一版国际贸易的WHO药品质量认证计划，并在当时接受GMP文档作为计划的一部分。在1975年，决议WHA28.65采用了修订后的认证体制和GMP文档。从那时起，认证计划已扩展到包括以下内容的认证：可食用动物所用兽药进出口成员国有关法规控制的药品所用的起始物料。证明药品安全性和有效性的资料（决议WHA41.18，1998）In 1992, the revised draft requirements
14、for GMP were presented in three parts, of which only Parts One and Two are reproduced in this document (1).1992年，修订后的GMP草案要求分为三个部分，其中只有1和2部分引入此文档中。“Quality management in the medicines industry: philosophy and essential elements”, outlines the general concepts of quality assurance (QA) as well as the
15、 principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspection, personnel, premises, equipment, materials and documentation.“制药企业的质量管理：GMP理念和基本要素”概述了质量保证和GMP主要要素或体系的基本概念，这是企业最高管理层以及生产和质量控制部门的共同职责。包括卫生、验证、自检、人员、厂房、设备、物料和文件等内容。“Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA.“生产和质量良好规范”分别为生产和质量控制人员的具体操作
