Annex 2(QC) 世界卫生组织药品微生物实验室管理规范.pdf

WHO 技术指南报告No. 961, 2011, annex 2 WHO 药品微生物实验室管理规范 © World Health Organization 世界卫生组织 WHO Technical Report Series, No. 961, 2011世界卫生组织技术报告系列，编号961，2011年 Annex 2 附录2 WHO good practices for pharmaceutical microbiology laboratories 世界卫生组织药品微生物实验室管理规范 目录 Background 背景2 Introduction and scope of document 文件介绍和范围2 Glossary 术语表3 1. Personnel 人员5 2. Environment 环境6 2.1 Premises 房屋6 2.3 Cleaning, disinfection and hygiene 清洁、消毒和卫生8 2.4 Sterility test facilities 无菌试验设施8 3. Validation of test methods 检验方法的验证10 4. Equipment 设备10 4.1 Maintenance of equipment 设备维护11 4.2 Qualification 验证11 4.3 Calibration, performance verification and monitoring of use 校准、性能确认和使用的监控11 4.3.3 Temperature measurement devices 温度测量装置 11 4.3.4 Incubators, water-baths and ovens 培养箱、水浴和烘箱 11 4.3.5 Autoclaves, including media preparators 高压灭菌锅，包括培养基制备器 12 4.3.6 Weights and balances 砝码和天平 13 4.3.7 Volumetric equipment 测定体积的设备 13 4.3.8 Other equipment 其他设备 13 5. Reagents and culture media 试剂和培养基14 5.1 Reagents 试剂14 5.2 Media 培养基14 5.3 Labelling 贴签16 5.4 Organism resuscitation 微生物复苏16 6. Reference materials and reference cultures 标准物质和标准菌株16 6.1 International standards and pharmacopoeial reference substances 国际标准和药典标准品16 6.2 Reference cultures 标准菌株17 7. Sampling 取样18 8. Sample handling and identification 样品处理和鉴定18 9. Disposal of contaminated waste 污染废物的处理19 10. Quality assurance of results and quality control of performance 结果的质量保证和性能的质 量控制19 10.1 Internal quality control 内部质量控制19 11. Testing procedures 检验程序20 12. Test reports 检验报告20 References 参考文件20 Further reading 补充书目21 Appendix 1 附件122