欧盟-GMP中英文对照.ppt

Pharmaceutical Services Corporation美国医药服务有限公司;What Is GMP?什么是GMP？;What Is GMP?什么是GMP？;A Brief History of GMPGMP历史简介;A Brief History of GMPGMP历史简介;GMP VariationsGMP的差异; The GMPs tell us what to do, they do not tell us how to do it. 药品生产管理规范告诉我们做什么，而不告诉我们怎样做。 How comes from: 怎样来源于： industry standard practice and guidelines 工业标准规范和指南 ;Commission Directive 2003/94/EC委员会条令2003/94/EC;Commission Directive 2003/94/EC委员会条令2003/94/EC;Commission Directive 2003/94/EC委员会条令2003/94/EC;EU Guidelines to GMP欧洲GMP指南;EU Guidelines to GMP欧洲GMP指南;EU Guidelines to GMP欧洲GMP指南;EU Guidelines to GMP欧洲GMP指南;Annex 11 Computerised Systems 附录十一 计算机系统 Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products 附录十二 药品生产过程中电离辐射的使用 Annex 13 Manufacture of Investigational Medicinal Products 附录十三 研究用药品的生产 Annex 14 Manufacture of Medicinal Products derived from Human Blood or Plasma 附录十四 来源于人体血液或血浆药品的生产 ;Annex 15 Qualification and Validation 附录十五 确认和验证 Annex 16 Certification by a Qualified Person and Batch Release 附录十六 药品放行责任人签发证书和放行批产品 Annex 17 Parametric Release 附录十七 参数放行 Annex 18 Not Used (was used for GMP for API) 附录十八 未使用（以前用于合成制药的生产管理规范） Annex 19 Reference and Retention samples 附录十九 对照样品和留样 Annex 20 Quality Risk Management 附录二十 质量风险管理 ;Who are the Regulators法规管理者是谁;All medicinal products for human and animal use derived from biotechnology and other high-technology processes must be approved via the centralised procedure. The same applies to all human medicines intended for the treatment of HIV/AIDS, cancer, diabetes or neurodegenerative diseases and for all designated orphan medicines intended for the treatment of rare diseases. 所有由生物技术及其它高科技工艺制备的人用药品和兽药产品，都必须通过集中审评程序报批。治疗艾滋病、肿瘤、糖尿病、神经退化以及罕见病的药物，也须按照集中审评程序报批。 ;For medicinal products that do not fall under any of the above-mentioned categories companies can submit an application for a centralised marketing authorisation to the EMEA, provided the m