欧盟药品GMP指南的目录

第一部分　欧盟药品管理概述
第二部分　欧盟GMP基本要求
引言
基本要求Ⅰ：人用药品及兽药制剂生产质量管理规范
基本要求Ⅱ：原料药生产质量管理规范
第三部分　欧盟GMP附录
欧盟GMP附录1　无菌药品的生产
欧盟GMP附录2　人用生物制品的生产
欧盟GMP附录3　放射性药品生产’
欧盟GMP附录4　兽用非免疫药品的生产
欧盟GMP附录5　免疫类兽药制品的生产
欧盟GMP附录6　医用气体生产
欧盟GMP附录7　草药制剂的生产
欧盟GMP附录8　原辅包装材料的取样
欧盟GMP附录9　液剂、霜剂和油膏的生产
欧盟GMP附录10　定量吸人式气雾剂的生产
欧盟GMP附录11　计算机系统
欧盟GMP附录12　药品生产中电离辐射的应用
欧盟GMP附录13　临床试验用药的生产
欧盟GMP附录14　人血液或血浆制品的生产
欧盟GMP附录15　确认和验证
欧盟GMP附录16　药品放行责任人签发证书和放行批产品
欧盟GMP附录17　参数放行
欧盟GMP附录19　对照样品和留样
欧盟GMP附录20　质量风险管理
欧盟GMP术语
第四部分　欧盟GMP原文
Introduction
Part Ⅰ-Chapter I Quatity management
Part Ⅱ-Basci Requirements for Active Substances used as Starting Materials
Annex 1 Manufacture of Sterile Medicinal Products
Annex 2 Manufacture of Biological Medicinal Products for Human Use
Annex 3 Manufacture of Radio Phannaceuticals
Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5 Manufacture of Immunological Veterinary Medicinal Products
Annex 6 Manufacture of Medicinal Gases
Annex 7 Manufacture of Herbal Medicinal Products
Annex 8 Sampling of Starting and Packaging Materials
Annex 9 Manufacture of Liquids, Creams and Ointments
Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Annex 11 Computerised Systems
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13 Manufacture of Investigational Medicinal Products
Annex 14 Manufacture of Products derived from Human Blood or Human Plasma
Annex 15 Qualification and validation (July 2001)
Annex 16 Certification by a Qualified Person and Batch Release (July 2001)
Annex 17 Parametric Release (July 2001)
Annex 19 Reference and Retention Samples (December 2005)
Annex 20 Quality Risk Management