_中英文_附录2 WHO药品GMP指南

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These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpc over.html). 这两部分随后通过药品GMP指南不可缺少的一部分内容进一步补充,这些内容 可在药品网站上查到: (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpc
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 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. 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
In 1969, when the World Health Assembly recommended the first version of the WHO Certification 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. Since 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
“Quality management in the medicines industry: philosophy and essential elements”, outlines the general concepts of quality assurance (QA) as well as the 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。
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 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。
gmp理念和基本元素pharmaceuticalqualitysystem制药质量体系qualityriskmanagement质量风险管理productqualityreview产品质量回顾goodmanufacturingpracticespharmaceuticalproducts药品gmphygiene清洁和卫生validation确认和验证complaints投诉productrecalls产品召回contractproductionanalysisotheractivities委托生产检验和其他活动general概述contractgiver委托方contractaccepter被委托方contract合同selfinspectionqualityauditssuppliersauditsapproval自检质量审计供应商审计和批准itemsselfinspection自检项目selfinspectionteam自检团队frequencyselfinspection自检频率selfinspectionreport自检报告followupaction后续措施qualityaudit质量审计suppliersauditsapproval供应商审计和批准personnel人员general概述keypersonnel关键人员10
legislation in both the exporting Member State and the importing Member State; — 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
“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提供了指南,以实 现质量保证的基本总则。
Annex 2 WHO good manufacducts: main principles 附录2 WHO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 management 质量风险管理 Product quality review 产品质量回顾 2. Good manufacturing practices for pharmaceutical products 药品GMP 3. 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 General 概述 The contract giver 委托方 The contract accepter 被委托方 The contract 合同 8. Self-inspection, quality audits and supplier’s 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 Suppliers’ audits and approval 供应商审计和批准
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 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。
Processing operations 生产操作 Packaging operations 包装操作 17. Good practices in quality control QC良好规范 Control 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 the 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 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。
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