欧洲药品GMP检查指南及(中英文)

1、GUIDE TO GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTS药品GMP检查指南. PIC/S July 2004Reproduction prohibited for commercial purposes.Reproduction for internal use is authorised,provided that the source is acknowledged.Editor: PIC/S SecretariatP.O. Box 5695CH-1211 Geneva 11e-mail: daniel.brunnerpicsch

2、web site: :/ 1 July 2004 PE 009-2TABLE OF CONTENT目录 TOC o 1-3 h z u HYPERLINK l _Toc112220217 INTRODUCTION介绍 PAGEREF _Toc112220217 h 1 HYPERLINK l _Toc112220218 CHAPTER 1 QUALITY MANAGEMENT 质量管理 PAGEREF _Toc112220218 h 4 HYPERLINK l _Toc112220219 PRINCIPLE 原则 PAGEREF _Toc11222021

3、9 h 4 HYPERLINK l _Toc112220220 QUALITY ASSURANCE 质量保证 PAGEREF _Toc112220220 h 4 HYPERLINK l _Toc112220221 GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP) 药品GMP PAGEREF _Toc112220221 h 6 HYPERLINK l _Toc112220222 QUALITY CONTROL 质量控制 PAGEREF _Toc112220222 h 7 HYPERLINK l _Toc112220223 CHAPT

4、ER 2 PERSONNEL 人员 PAGEREF _Toc112220223 h 10 HYPERLINK l _Toc112220224 PRINCIPLE 原则 PAGEREF _Toc112220224 h 10 HYPERLINK l _Toc112220225 GENERAL 通则 PAGEREF _Toc112220225 h 10 HYPERLINK l _Toc112220226 KEY PERSONNEL 关键人员 PAGEREF _Toc112220226 h 10 HYPERLINK l _Toc112220227 TRAINING 培训 PAGEREF _Toc112

5、220227 h 13 HYPERLINK l _Toc112220228 PERSONAL HYGIENE 个人卫生 PAGEREF _Toc112220228 h 14 HYPERLINK l _Toc112220229 CHAPTER 3 PREMISES AND EQUIPMENT 厂房和设备 PAGEREF _Toc112220229 h 16 HYPERLINK l _Toc112220230 PRINCIPLE 原则 PAGEREF _Toc112220230 h 16 HYPERLINK l _Toc112220231 PREMISES General总则 PAGEREF _T

6、oc112220231 h 16 HYPERLINK l _Toc112220232 Production Area 生产区域 PAGEREF _Toc112220232 h 17 HYPERLINK l _Toc112220233 Storage Areas 储存区域 PAGEREF _Toc112220233 h 19 HYPERLINK l _Toc112220234 Quality Control Areas 质量控制区域 PAGEREF _Toc112220234 h 20 HYPERLINK l _Toc112220235 Ancillary Areas 辅助区域 PAGEREF

7、_Toc112220235 h 20 HYPERLINK l _Toc112220236 EQUIPMENT 设备 PAGEREF _Toc112220236 h 21 HYPERLINK l _Toc112220237 CHAPTER 4 DOCUMENTATION 文件 PAGEREF _Toc112220237 h 23 HYPERLINK l _Toc112220238 PRINCIPLE 原则 PAGEREF _Toc112220238 h 23 HYPERLINK l _Toc112220239 GENERAL 总则 PAGEREF _Toc112220239 h 23 HYPER

8、LINK l _Toc112220240 DOCUMENTS REQUIRED 必需的文件 PAGEREF _Toc112220240 h 25 HYPERLINK l _Toc112220241 MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 生产方法和加工指示 PAGEREF _Toc112220241 h 27 HYPERLINK l _Toc112220242 PACKAGING INSTRUCTIONS 包装指示 PAGEREF _Toc112220242 h 28 HYPERLINK l _Toc112220243 BATCH P

9、ROCESSING RECORDS 批加工记录 PAGEREF _Toc112220243 h 29 HYPERLINK l _Toc112220244 BATCH PACKAGING RECORDS 批包装记录 PAGEREF _Toc112220244 h 30 HYPERLINK l _Toc112220245 PROCEDURES AND RECORDS 程序和记录 PAGEREF _Toc112220245 h 32 HYPERLINK l _Toc112220246 CHAPTER 5 PRODUCTION 生产 PAGEREF _Toc112220246 h 36 HYPERLI

10、NK l _Toc112220247 PRINCIPLE 原则 PAGEREF _Toc112220247 h 36 HYPERLINK l _Toc112220248 GENERAL 通则 PAGEREF _Toc112220248 h 36 HYPERLINK l _Toc112220249 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 生产过程中防止交叉污染 PAGEREF _Toc112220249 h 38 HYPERLINK l _Toc112220250 VALIDATION 验证 PAGEREF _Toc112220250 h

11、39 HYPERLINK l _Toc112220251 STARTING MATERIALS 起始物料 PAGEREF _Toc112220251 h 40 HYPERLINK l _Toc112220252 PROCESSING OPERATIONS - INTERMEDIATE AND BULK PRODUCTS 加工操作：中间体和散装产品 PAGEREF _Toc112220252 h 42 HYPERLINK l _Toc112220253 PACKAGING MATERIALS 包装材料 PAGEREF _Toc112220253 h 42 HYPERLINK l _Toc1122

12、20254 PACKAGING OPERATIONS 包装操作 PAGEREF _Toc112220254 h 43 HYPERLINK l _Toc112220255 FINISHED PRODUCTS 最终成品 PAGEREF _Toc112220255 h 45 HYPERLINK l _Toc112220256 REJECTED, RECOVERED AND RETURNED MATERIALS 拒绝的，回收的和退回的物料 PAGEREF _Toc112220256 h 46 HYPERLINK l _Toc112220257 CHAPTER 6 QUALITY CONTROL 质量控

13、制 PAGEREF _Toc112220257 h 48 HYPERLINK l _Toc112220258 PRINCIPLE 原则 PAGEREF _Toc112220258 h 48 HYPERLINK l _Toc112220259 GENERAL 通则 PAGEREF _Toc112220259 h 48 HYPERLINK l _Toc112220260 GOOD QUALITY CONTROL LABORATORY PRACTICE 优良质量控制实验室实践 PAGEREF _Toc112220260 h 49 HYPERLINK l _Toc112220261 DOCUMENTA

14、TION 文件 PAGEREF _Toc112220261 h 49 HYPERLINK l _Toc112220262 SAMPLING 取样 PAGEREF _Toc112220262 h 50 HYPERLINK l _Toc112220263 TESTING 检测 PAGEREF _Toc112220263 h 52 HYPERLINK l _Toc112220264 CHAPTER 7 CONTRACT MANUFACTURE AND ANALYSIS 合同加工和分析 PAGEREF _Toc112220264 h 55 HYPERLINK l _Toc112220265 PRINC

15、IPLE 原则 PAGEREF _Toc112220265 h 55 HYPERLINK l _Toc112220266 GENERAL 通则 PAGEREF _Toc112220266 h 55 HYPERLINK l _Toc112220267 THE CONTRACT GIVER 合同提供人 PAGEREF _Toc112220267 h 55 HYPERLINK l _Toc112220268 THE CONTRACT ACCEPTOR 合同接受人 PAGEREF _Toc112220268 h 56 HYPERLINK l _Toc112220269 THE CONTRACT 合同

16、PAGEREF _Toc112220269 h 57 HYPERLINK l _Toc112220270 CHAPTER 8 COMPLAINTS AND PRODUCT RECALL 抱怨和产品召回 PAGEREF _Toc112220270 h 59 HYPERLINK l _Toc112220271 PRINCIPLE 原则 PAGEREF _Toc112220271 h 59 HYPERLINK l _Toc112220272 COMPLAINTS 抱怨 PAGEREF _Toc112220272 h 59 HYPERLINK l _Toc112220273 RECALLS 召回 PA

17、GEREF _Toc112220273 h 60 HYPERLINK l _Toc112220274 CHAPTER 9 SELF INSPECTION 自检 PAGEREF _Toc112220274 h 61 HYPERLINK l _Toc112220275 PRINCIPLE 原则 PAGEREF _Toc112220275 h 61 HYPERLINK l _Toc112220276 ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS无菌药品的生产 PAGEREF _Toc112220276 h 63 HYPERLINK l _Toc1

18、12220277 PRINCIPLE PAGEREF _Toc112220277 h 63 HYPERLINK l _Toc112220278 GENERAL PAGEREF _Toc112220278 h 63 HYPERLINK l _Toc112220279 BLOW/FILL/SEAL TECHNOLOGY PAGEREF _Toc112220279 h 67 HYPERLINK l _Toc112220280 TERMINALLY STERILISED PRODUCTS PAGEREF _Toc112220280 h 67 HYPERLINK l _Toc112220281 ASEP

19、TIC PREPARATION PAGEREF _Toc112220281 h 68 HYPERLINK l _Toc112220282 PERSONNEL PAGEREF _Toc112220282 h 68 HYPERLINK l _Toc112220283 PREMISES PAGEREF _Toc112220283 h 70 HYPERLINK l _Toc112220284 EQUIPMENT PAGEREF _Toc112220284 h 71 HYPERLINK l _Toc112220285 SANITATION PAGEREF _Toc112220285 h 71 HYPER

20、LINK l _Toc112220286 PROCESSING PAGEREF _Toc112220286 h 71 HYPERLINK l _Toc112220287 STERILISATION PAGEREF _Toc112220287 h 73 HYPERLINK l _Toc112220288 STERILISATION BY HEAT PAGEREF _Toc112220288 h 74 HYPERLINK l _Toc112220289 MOIST HEAT PAGEREF _Toc112220289 h 75 HYPERLINK l _Toc112220290 DRY HEAT

21、PAGEREF _Toc112220290 h 75 HYPERLINK l _Toc112220291 STERILISATION BY RADIATION PAGEREF _Toc112220291 h 75 HYPERLINK l _Toc112220292 STERILISATION WITH ETHYLENE OXIDE PAGEREF _Toc112220292 h 76 HYPERLINK l _Toc112220293 FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE STERILISED IN THEIR FINAL CONTA

22、INER PAGEREF _Toc112220293 h 77 HYPERLINK l _Toc112220294 FINISHING OF STERILE PRODUCTS PAGEREF _Toc112220294 h 77 HYPERLINK l _Toc112220295 QUALITY CONTROL PAGEREF _Toc112220295 h 78 HYPERLINK l _Toc112220296 ANNEX 2 MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE人用生物药品的生产 PAGEREF _Toc11

23、2220296 h 79 HYPERLINK l _Toc112220297 SCOPE PAGEREF _Toc112220297 h 79 HYPERLINK l _Toc112220298 PRINCIPLE PAGEREF _Toc112220298 h 79 HYPERLINK l _Toc112220299 PERSONNEL PAGEREF _Toc112220299 h 80 HYPERLINK l _Toc112220300 PREMISES AND EQUIPMENT PAGEREF _Toc112220300 h 81 HYPERLINK l _Toc112220301

24、ANIMAL QUARTERS AND CARE PAGEREF _Toc112220301 h 82 HYPERLINK l _Toc112220302 DOCUMENTATION PAGEREF _Toc112220302 h 82 HYPERLINK l _Toc112220303 PRODUCTION PAGEREF _Toc112220303 h 83 HYPERLINK l _Toc112220304 QUALITY CONTROL PAGEREF _Toc112220304 h 84 HYPERLINK l _Toc112220305 ANNEX 3 MANUFACTURE OF

25、 RADIOPHARMACEUTICALS 放射性药品的生产 PAGEREF _Toc112220305 h 85 HYPERLINK l _Toc112220306 PRINCIPLE PAGEREF _Toc112220306 h 85 HYPERLINK l _Toc112220307 PERSONNEL PAGEREF _Toc112220307 h 85 HYPERLINK l _Toc112220308 PREMISES AND EQUIPMENT PAGEREF _Toc112220308 h 85 HYPERLINK l _Toc112220309 PRODUCTION PAG

26、EREF _Toc112220309 h 86 HYPERLINK l _Toc112220310 QUALITY CONTROL PAGEREF _Toc112220310 h 86 HYPERLINK l _Toc112220311 DISTRIBUTION AND RECALLS PAGEREF _Toc112220311 h 86 HYPERLINK l _Toc112220312 ANNEX 4 MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICALS MANUFACTURE OF PREMIXES

27、FOR MEDICATED FEEDING STUFFS 除为预混合加药饲料原料生产的免疫产品以外的，兽药产品的生产 PAGEREF _Toc112220312 h 87 HYPERLINK l _Toc112220313 THE MANUFACTURE OF ECTOPARASITICIDES PAGEREF _Toc112220313 h 88 HYPERLINK l _Toc112220314 THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS CONTAINING PENICILLINS PAGEREF _Toc112220314 h 88

28、 HYPERLINK l _Toc112220315 RETENTION OF SAMPLES (point 1.4. viii and point 6.14.) PAGEREF _Toc112220315 h 88 HYPERLINK l _Toc112220316 STERILE VETERINARY MEDICINAL PRODUCTS PAGEREF _Toc112220316 h 88 HYPERLINK l _Toc112220317 ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICAL PRODUCTS免疫兽药产品的生产

29、PAGEREF _Toc112220317 h 89 HYPERLINK l _Toc112220318 PRINCIPLE PAGEREF _Toc112220318 h 89 HYPERLINK l _Toc112220319 PERSONNEL PAGEREF _Toc112220319 h 89 HYPERLINK l _Toc112220320 PREMISES PAGEREF _Toc112220320 h 90 HYPERLINK l _Toc112220321 EQUIPMENT PAGEREF _Toc112220321 h 93 HYPERLINK l _Toc112220

30、322 ANIMALS AND ANIMAL HOUSES PAGEREF _Toc112220322 h 94 HYPERLINK l _Toc112220323 DISINFECTION - WASTE DISPOSAL PAGEREF _Toc112220323 h 94 HYPERLINK l _Toc112220324 PRODUCTION PAGEREF _Toc112220324 h 95 HYPERLINK l _Toc112220325 STARTING MATERIALS PAGEREF _Toc112220325 h 95 HYPERLINK l _Toc11222032

31、6 QUALITY CONTROL PAGEREF _Toc112220326 h 98 HYPERLINK l _Toc112220327 ANNEX 6 MANUFACTURE OF MEDICINAL GASES药用气体的生产 PAGEREF _Toc112220327 h 99 HYPERLINK l _Toc112220328 1. PRINCIPLE PAGEREF _Toc112220328 h 99 HYPERLINK l _Toc112220329 2. PERSONNEL PAGEREF _Toc112220329 h 99 HYPERLINK l _Toc11222033

32、0 3. PREMISES AND EQUIPMENT PAGEREF _Toc112220330 h 99 HYPERLINK l _Toc112220331 4. DOCUMENTATION PAGEREF _Toc112220331 h 100 HYPERLINK l _Toc112220332 5. PRODUCTION PAGEREF _Toc112220332 h 101 HYPERLINK l _Toc112220333 6. QUALITY CONTROL PAGEREF _Toc112220333 h 104 HYPERLINK l _Toc112220334 7. STOR

33、AGE AND RELEASE PAGEREF _Toc112220334 h 105 HYPERLINK l _Toc112220335 ANNEX 7 MANUFACTURE OF HERBAL MEDICINAL PRODUCTS草药产品的生产 PAGEREF _Toc112220335 h 108 HYPERLINK l _Toc112220336 PRINCIPLE PAGEREF _Toc112220336 h 108 HYPERLINK l _Toc112220337 PREMISES PAGEREF _Toc112220337 h 108 HYPERLINK l _Toc112

34、220338 DOCUMENTATION PAGEREF _Toc112220338 h 108 HYPERLINK l _Toc112220339 SAMPLING PAGEREF _Toc112220339 h 109 HYPERLINK l _Toc112220340 QUALITY CONTROL PAGEREF _Toc112220340 h 110 HYPERLINK l _Toc112220341 ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS起始物料和包装材料的取样 PAGEREF _Toc112220341 h 111

35、 HYPERLINK l _Toc112220342 PRINCIPLE PAGEREF _Toc112220342 h 111 HYPERLINK l _Toc112220343 PERSONNEL PAGEREF _Toc112220343 h 111 HYPERLINK l _Toc112220344 STARTING MATERIALS PAGEREF _Toc112220344 h 111 HYPERLINK l _Toc112220345 PACKAGING MATERIAL PAGEREF _Toc112220345 h 112 HYPERLINK l _Toc112220346

36、 ANNEX 9 MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS流体，霜体和膏体药品的生产 PAGEREF _Toc112220346 h 113 HYPERLINK l _Toc112220347 PRINCIPLE PAGEREF _Toc112220347 h 113 HYPERLINK l _Toc112220348 PRODUCTION PAGEREF _Toc112220348 h 113 HYPERLINK l _Toc112220349 ANNEX 10 MANUFACTURE OF PRESSURISED METERED DOSE A

37、EROSOL PREPARATIONS FOR INHALATION吸入式剂量仪的气雾剂的生产 PAGEREF _Toc112220349 h 115 HYPERLINK l _Toc112220350 PRINCIPLE PAGEREF _Toc112220350 h 115 HYPERLINK l _Toc112220351 GENERAL PAGEREF _Toc112220351 h 115 HYPERLINK l _Toc112220352 PREMISES AND EQUIPMENT PAGEREF _Toc112220352 h 115 HYPERLINK l _Toc11222

38、0353 PRODUCTION AND QUALITY CONTROL PAGEREF _Toc112220353 h 116 HYPERLINK l _Toc112220354 ANNEX 11 COMPUTERISED SYSTEMS 计算机化系统 PAGEREF _Toc112220354 h 117 HYPERLINK l _Toc112220355 PRINCIPLE PAGEREF _Toc112220355 h 117 HYPERLINK l _Toc112220356 PERSONNEL PAGEREF _Toc112220356 h 117 HYPERLINK l _Toc1

39、12220357 VALIDATION PAGEREF _Toc112220357 h 117 HYPERLINK l _Toc112220358 ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS使用离子放射生产药品 PAGEREF _Toc112220358 h 120 HYPERLINK l _Toc112220359 INTRODUCTION PAGEREF _Toc112220359 h 120 HYPERLINK l _Toc112220360 RESPONSIBILITIES PA

40、GEREF _Toc112220360 h 120 HYPERLINK l _Toc112220361 DOSIMETRY PAGEREF _Toc112220361 h 121 HYPERLINK l _Toc112220362 VALIDATION OF THE PROCESS PAGEREF _Toc112220362 h 121 HYPERLINK l _Toc112220363 COMMISSIONING OF THE PLANT PAGEREF _Toc112220363 h 122 HYPERLINK l _Toc112220364 PREMISES PAGEREF _Toc11

41、2220364 h 124 HYPERLINK l _Toc112220365 PROCESSING PAGEREF _Toc112220365 h 124 HYPERLINK l _Toc112220366 DOCUMENTATION PAGEREF _Toc112220366 h 126 HYPERLINK l _Toc112220367 MICROBIOLOGICAL MONITORING PAGEREF _Toc112220367 h 126 HYPERLINK l _Toc112220368 ANNEX 13 MANUFACTURE OF INVESTIGATIONAL MEDICI

42、NAL PRODUCTS观察期药品的生产 PAGEREF _Toc112220368 h 127 HYPERLINK l _Toc112220369 PRINCIPLE PAGEREF _Toc112220369 h 127 HYPERLINK l _Toc112220370 GLOSSARY PAGEREF _Toc112220370 h 128 HYPERLINK l _Toc112220371 QUALITY MANAGEMENT PAGEREF _Toc112220371 h 130 HYPERLINK l _Toc112220372 PERSONNEL PAGEREF _Toc112

43、220372 h 130 HYPERLINK l _Toc112220373 PREMISES AND EQUIPMENT PAGEREF _Toc112220373 h 130 HYPERLINK l _Toc112220374 DOCUMENT ATION PAGEREF _Toc112220374 h 131 HYPERLINK l _Toc112220375 PRODUCTION PAGEREF _Toc112220375 h 132 HYPERLINK l _Toc112220376 QUALITY CONTROL PAGEREF _Toc112220376 h 136 HYPERL

44、INK l _Toc112220377 RELEASE OF BATCHES PAGEREF _Toc112220377 h 137 HYPERLINK l _Toc112220378 SHIPPING PAGEREF _Toc112220378 h 139 HYPERLINK l _Toc112220379 COMPLAINTS PAGEREF _Toc112220379 h 139 HYPERLINK l _Toc112220380 RECALLS AND RETURNS PAGEREF _Toc112220380 h 139 HYPERLINK l _Toc112220381 DESTR

45、UCTION PAGEREF _Toc112220381 h 140 HYPERLINK l _Toc112220382 ANNEX 14 MANUFACTURE OF PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA生产自人类血液或人体组织分离的产品 PAGEREF _Toc112220382 h 143 HYPERLINK l _Toc112220383 PRINCIPLE PAGEREF _Toc112220383 h 143 HYPERLINK l _Toc112220384 GLOSSARY PAGEREF _Toc112220384

46、 h 144 HYPERLINK l _Toc112220385 QUALITY MANAGEMENT PAGEREF _Toc112220385 h 144 HYPERLINK l _Toc112220386 PREMISES AND EQUIPMENT PAGEREF _Toc112220386 h 145 HYPERLINK l _Toc112220387 BLOOD AND PLASMA COLLECTION PAGEREF _Toc112220387 h 145 HYPERLINK l _Toc112220388 TRACEABILITY AND POST COLLECTION ME

47、ASURES PAGEREF _Toc112220388 h 146 HYPERLINK l _Toc112220389 PRODUCTION AND QUALITY CONTROL PAGEREF _Toc112220389 h 147 HYPERLINK l _Toc112220390 RETENTION OF SAMPLES PAGEREF _Toc112220390 h 148 HYPERLINK l _Toc112220391 DISPOSAL OF REJECTED BLOOD, PLASMA OR INTERMEDIATES PAGEREF _Toc112220391 h 148

48、 HYPERLINK l _Toc112220392 ANNEX 15 QUALIFICATION AND VALIDATION 确认和验证 PAGEREF _Toc112220392 h 149 HYPERLINK l _Toc112220393 PRINCIPLE PAGEREF _Toc112220393 h 149 HYPERLINK l _Toc112220394 PLANNING FOR VALIDATION PAGEREF _Toc112220394 h 149 HYPERLINK l _Toc112220395 DOCUMENTATION PAGEREF _Toc1122203

49、95 h 150 HYPERLINK l _Toc112220396 QUALIFICATION PAGEREF _Toc112220396 h 150 HYPERLINK l _Toc112220397 PROCESS VALIDATION PAGEREF _Toc112220397 h 151 HYPERLINK l _Toc112220398 CLEANING VALIDATION PAGEREF _Toc112220398 h 153 HYPERLINK l _Toc112220399 CHANGE CONTROL PAGEREF _Toc112220399 h 154 HYPERLI

50、NK l _Toc112220400 REVALIDATION PAGEREF _Toc112220400 h 154 HYPERLINK l _Toc112220401 GLOSSARY PAGEREF _Toc112220401 h 154 HYPERLINK l _Toc112220402 ANNEX 16 QUALIFIED PERSON AND BATCH RELEASE*经授权的人员和批放行 PAGEREF _Toc112220402 h 157 HYPERLINK l _Toc112220403 ANNEX 17 PARAMETRIC RELEASE参数放行 PAGEREF _T

51、oc112220403 h 158 HYPERLINK l _Toc112220404 1. PRINCIPLE PAGEREF _Toc112220404 h 158 HYPERLINK l _Toc112220405 2. PARAMETRIC RELEASE PAGEREF _Toc112220405 h 158 HYPERLINK l _Toc112220406 3. PARAMETRIC RELEASE FOR STERILE PRODUCTS PAGEREF _Toc112220406 h 158 HYPERLINK l _Toc112220407 4. GLOSSARY PAGE

52、REF _Toc112220407 h 160 HYPERLINK l _Toc112220408 ANNEX 18 GMP GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS 17原料药GMP指南 PAGEREF _Toc112220408 h 161 HYPERLINK l _Toc112220409 GLOSSARY术语表 PAGEREF _Toc112220409 h 162GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS药品GMP指南INTRODUCTION介绍为进一步消除药品贸

53、易壁垒，促进许可证的一致性，以及确保整个欧洲在研发，生产和控制药品中保持高标准的质量保证，根据药品检查协会（PIC）同意，药品检查使用一致的GMP原则，和药品检查合作计划表中的欧洲药品GMP及其附录。In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance

54、 in the development, manufacture and control of medicinal products throughout Europe, it was agreed to harmonise the rules of GMP applied under Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to those of the EU Guide to Good Manufacturing Prac

55、tice for Medicinal Products and its Annexes. 为了将欧洲指南改编成适合协会的要求和目的，进行了最小的编辑变化。这些变化如下： 药品的定义 （参见本指南对药品的定义），保留了药品检查协会的第一章的定义； 删除了对欧洲法规的参考； 由于药品检查协会没有“有资质人员”的定义，这个定义被替换成“经授权人员”（见术语表）； 由于药品检查协会的参与国或参与的官方机构不是欧洲药典委员会的成员，本指南中的“欧洲药典”应理解成“欧洲药典或其他相关药典”。A minimum of editorial changes have, however, been necessa

56、ry to adapt the text of the EU Guide to the Conventions purposes and requirements. Those changes are the following: . the definition of Pharmaceutical Product (referred to as “Medicinal Product” in this Guide) which is found in Article 1 of the Pharmaceutical Inspection Convention has been retained;

57、 . references to the EU Directives have been deleted; . as the expression Qualified Person does not exist under the PIC or PIC/S , it has been replaced by authorised person (see Glossary) . since all the Contracting States to the PIC Convention or Participating Authorities under the PIC Scheme are n

58、ot parties to the European Pharmacopoeia Convention, the mention of European Pharmacopoeia in the Guide has been amended to read European or other relevant Pharmacopoeia. 本指南所包括的标准和原则是按照药品检查协会或药品检查合作计划表的要求进行生产实践的参考信息。The standards and principles contained in this Guide are intended to serve as a ref

59、erence for the preparation of information on manufacturing practice as requested under the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme. 各国卫生部的行政措施应本着应用这些标准于实践的方针，任何新的或修订的各国GMP法规应至少符合本标准的水平。Administrative measures of national health authorities should be d

60、irected towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. 这些标准也是生产企业的基本工业管理原则。These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules