第一部分 欧盟药品管理概述 1
第二部分 欧盟GMP基本要求 33
引言 35
基本要求Ⅰ：人用药品及兽药制剂生产质量管理规范 37
基本要求Ⅱ：原料药生产质量管理规范 64
第三部分 欧盟GMP附录 103
欧盟GMP附录1无菌药品的生产 105
欧盟GMP附录2人用生物制品的生产 119
欧盟GMP附录3放射性药品生产 126
欧盟GMP附录4兽用非免疫药品的生产 130
欧盟GMP附录5免疫类兽药制品的生产 134
欧盟GMP附录6医用气体生产 143
欧盟GMP附录7草药制剂的生产 152
欧盟GMP附录8原辅包装材料的取样 156
欧盟GMP附录9液剂、霜剂和油膏的生产 160
欧盟GMP附录10定量吸入式气雾剂的生产 163
欧盟GMP附录11计算机系统 166
欧盟GMP附录12药品生产中电离辐射的应用 170
欧盟GMP附录13临床试验用药的生产 177
欧盟GMP附录14人血液或血浆制品的生产 191
欧盟GMP附录15确认和验证 197
欧盟GMP附录16药品放行责任人签发证书和放行批产品 206
欧盟GMP附录17参数放行 215
欧盟GMP附录19对照样品和留样 219
欧盟GMP附录20质量风险管理 224
欧盟GMP术语 241
第四部分 欧盟GMP原文 249
Introduction 251
PartⅠ -Chapter Ⅰ Quatity management 254
PartⅡ -Basci Requirements for Active Substances used as Starting Materials 297
Annex 1 Manufacture of Sterile Medicinal Products 354
Annex 2 Manufacture of Biological Medicinal Products for Human Use 376
Annex 3 Manufacture of Radio Pharmaceuticals 382
Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products 384
Annex 5 Manufacture of Immunological Veterinary Medicinal Products 386
Annex 6 Manufacture of Medicinal Gases 396
Annex 7 Manufacture of Herbal Medicinal Products 406
Annex 8 Sampling of Starting and Packaging Materials 409
Annex 9 Manufacture of Liquids，Creams and Ointments 411
Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation 412
Annex 11 Computerised Systems 414
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products 417
Annex 13 Manufacture of Investigational Medicinal Products 424
Annex 14 Manufacture of Products derived from Human Blood or Human Plasma 448
Annex 15 Qualification and validation（July 2001） 455
Annex 16 Certification by a Qualified Person and Batch Release（July 2001） 465
Annex 17 Parametric Release（July 2001） 475
Annex 19 Reference and Retention Samples（December 2005） 480
Annex 20 Quality Risk Management 486