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定量吸入式气雾剂的生产

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

PartⅠ -Chapter Ⅰ Quatity management

PartⅡ -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 Pharmaceuticals

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