GMP实施指南-原料药 (2010版) 中文版

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原料药 GMP 实施指南目录

目录

1. 前言 .............................................................................................................................................. 1

1.1目的....................................................................................................................................1

1.2适用性................................................................................................................................1

1.3范围和结构........................................................................................................................3

2. 质量管理 ...................................................................................................................................... 6

2.1总则....................................................................................................................................6

2.2质量部门的职责................................................................................................................8

2.3生产部门的职责..............................................................................................................11

2.4自检（内审）..................................................................................................................12

2.5产品质量回顾..................................................................................................................14

2.6质量风险管理..................................................................................................................24

3. 人员 ............................................................................................................................................ 32

3.1人员资质..........................................................................................................................32

3.2员工培训........................................................................................................................35

3.3人员卫生..........................................................................................................................42

3.4顾问..................................................................................................................................44

4. 厂房与设施 ................................................................................................................................ 46

4.1设计与建造......................................................................................................................49

4.2 公用设施...........................................................................................................................68

4.3水......................................................................................................................................72

4.4特殊隔离要求..................................................................................................................74

4.5照明..................................................................................................................................79

4.6排污和垃圾......................................................................................................................79

4.7清洁和保养......................................................................................................................80

5. 设备 ............................................................................................................................................ 83

5.1设计和建造......................................................................................................................83

5.2设备维护保养和清洁......................................................................................................97

5.3校准................................................................................................................................112

5.4计算机化系统................................................................................................................119

6. 文件与记录 .............................................................................................................................. 127

6.1文件系统和质量标准....................................................................................................127

6.2设备使用日志..............................................................................................................133

6.3原料、中间体、原料药的标签和包装材料的记录..................................................134

6.4生产工艺规程................................................................................................................135

6.5批生产记录及批包装记录..........................................................................................137

6.6实验室控制记录..........................................................................................................140

6.7批生产记录审核............................................................................................................143

7. 物料管理 .................................................................................................................................. 145

7.1一般原则......................................................................................................................145

7.2接收和待验....................................................................................................................154

7.3进厂物料的取样与检验..............................................................................................157

7.4储存................................................................................................................................161

7.5复验................................................................................................................................170

8. 生产和过程控制 ...................................................................................................................... 173

8.1生产操作........................................................................................................................173

8.2时限..............................................................................................................................181

8.3工序取样和控制............................................................................................................182

目录原料药 GMP 实施指南

8.4中间体或原料药的混合批次........................................................................................185

8.5污染控制........................................................................................................................187

9. 原料药和中间体的包装和贴签 .............................................................................................. 192

9.1总则................................................................................................................................192

9.2包装材料........................................................................................................................194

9.3标签发放与控制............................................................................................................195

9.4包装与贴签操作............................................................................................................197

10. 储存和分发 ............................................................................................................................ 199

10.1储存程序......................................................................................................................199

10.2分发程序......................................................................................................................203

11. 实验室控制 ............................................................................................................................ 206

11.1控制通则....................................................................................................................207

11.2取样..............................................................................................................................212

11.3质量标准....................................................................................................................215

11.4中间体和原料药的测试..............................................................................................224

11.5分析方法验证..............................................................................................................229

11.6检验报告及批产品放行..............................................................................................232

11.7原料药的稳定性监测..................................................................................................233

11.8有效期和复验期..........................................................................................................235

11.9留样..............................................................................................................................237

11.10微生物检验................................................................................................................239

12. 验证 ........................................................................................................................................ 240

12.1 验证方针.......................................................................................................................241

12.2 验证文件.......................................................................................................................246

12.3 确认...............................................................................................................................249

12.4工艺验证的方法和程序..............................................................................................259

12.5 验证系统的定期审核...................................................................................................265

12.6清洁验证......................................................................................................................267

12.7 分析方法的验证...........................................................................................................276

13. 变更控制 ................................................................................................................................ 277

14. 拒收和物料的再利用 ............................................................................................................ 298

14.1拒收..............................................................................................................................298

14.2返工..............................................................................................................................301

14.3重新加工......................................................................................................................306

14.4 物料与溶剂的回收.......................................................................................................311

14.5退货..............................................................................................................................314

15. 投诉与召回 ............................................................................................................................ 318

15.1投诉..............................................................................................................................318

15.2 召回...............................................................................................................................321

16. 委托生产和委托检验 ............................................................................................................ 323

17. 代理商、中间商、贸易商、分销商、分装商和再贴签商 ................................................ 336

17.1适用性..........................................................................................................................336

17.1.1中国法规的要求...............................................................................................336

17.1.2基于 ICHQ7 的做法........................................................................................336

17.2已分发原料药的可追溯性..........................................................................................336

17.3 质量管理.......................................................................................................................339

17.4原料药和中间体的重新包装、重新贴签和保存......................................................339

17.5稳定性..........................................................................................................................340

17.6信息的传递..................................................................................................................342

17.7投诉和召回的处理......................................................................................................344

17.8退货的处理..................................................................................................................345

原料药 GMP 实施指南目录

iii

18. 采用发酵工艺生产原料药的特殊要求 ................................................................................ 346

18.1细胞库的维护和记录的保存......................................................................................346

18.2菌种培养和发酵..........................................................................................................350

18.3收集、分离和纯化......................................................................................................356

18.4病毒去除/灭活步骤....................................................................................................359

19. 用于临床研究的原料药 ........................................................................................................ 362

20. 无菌原料药 ............................................................................................................................ 366

20.1无菌原料药工艺特点分析..........................................................................................366

20.2厂房设施设备..............................................................................................................368

20.3生产过程管理..............................................................................................................378

20.3.1生产工艺...........................................................................................................378

20.3.2设备清洗灭菌、生产周期管理.......................................................................388

20.4除菌过滤......................................................................................................................389

20.5无菌原料药生产对环境的控制..................................................................................

391

20.5.1 无菌原料药生产过程中特殊操作对环境洁净度的要求：............................391

20.5.2 穿越不同级别人流、物流的注意事项............................................................393

20.5.3 无菌原料药生产对微粒和微生物的影响........................................................394

20.6针对于无菌原理药特点的验证方法分析：..............................................................396

20.5.1培养基灌装.......................................................................................................396

20.5.2设备灭菌验证...................................................................................................399

20.6.3灭菌验证...........................................................................................................402

20.6.4工艺验证：.......................................................................................................402

20.7实验室测试..................................................................................................................403

20.7.1无菌原料药生产用物料的检验.......................................................................404

20.7.2无菌原料药工艺过程中的检测.......................................................................405

20.7.3无菌原料药产品的检验...................................................................................412

20.8包装..............................................................................................................................

415

参考资料 ....................................................................................................................................... 420

词汇表 ........................................................................................................................................... 422

术语表 ........................................................................................................................................... 425

关键词列表 ................................................................................................................................... 442

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摘要：

《GMP实施指南-原料药 (2010版) 中文版》是针对药品生产质量管理规范在原料药生产环节中的权威技术指导文件，适用于制药企业、质量管理人员及合规审核人员。该指南系统梳理了原料药生产中从起始物料到最终产品的全流程管理要求，涵盖厂房设备、工艺验证、清洁验证、污染控制、偏差处理及文件管理等关键环节，并结合2010年修订版GMP标准，提供了可操作的实施要点与风险控制策略。本书旨在帮助企业提升原料药生产的质量一致性、合规性与安全性，是制药行业人员深入理解并落实GMP规范的重要参考资料。

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