欧盟药品GMP指南PDF电子书下载

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