冷库验证的指南或标准

xiaodong

目前在做冷库的验证，请教大神这方面参考什么指南？

枫林之秋

GSP《药品经营质量管理规范》附录5 验证管理
GB/T 34399-2017医药产品冷链物流温控设施设备验证性能确认技术规范
WHO第961号技术报告附录9：时间和温度敏感药品贮运指南
USP 40<1079> 药品良好的储存和分销实践
PDA TR64 有源温度受控系统：确认指南
GSP附录3：温湿度自动监测

光风霁月

Laws & Regulations:
1. National Medical Products Administration (NMPA), China, Good Manufacturing Practice (2010 Revision), March, 2011
2. National Medical Products Administration (NMPA), China, Good Manufacturing Practice (2010 Revision), Annex, Qualification and Validation, 2015
3. National Medical Products Administration (NMPA), China, Good Supply Practice, July, 2016
4. GB/T 34399-2017 Temperature control facilities of pharmaceutical products cold chain logistics - Specification for performance qualification, May, 2018
5. Eudralex Volume 4 EU Guidelines to Good Manufacturing Practice Medical Products for Human and Veterinary Use, Annex 15: Qualification and Validation, March, 2015

Guidelines:
1. ISPE Baseline Guide, Volume 5: Commissioning and Qualification, First Edition, 2001
2. ISPE Baseline Guide, Volume 5: Commissioning and Qualification, Second Edition, 2019
3. ISPE Good Practice Guide, Heating, Ventilation, and Air Conditioning (HVAC), 2009
3. ISPE Good Practice Guide, Applied Risk Management for Commissioning and Qualification, 2011
4. ISPE Good Practice Guide, Cold Chain Management, 2011
5. ISPE Good Practice Guide, Packing, Labeling, and Warehousing Facilities, 2012
5. ISPE Good Practice Guide, Controlled Temperature Chamber Mapping & Monitoring, 2016
6. ISPE Guide, Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
7. PDA Technical Report No.64, Active Temperature-Controlled Systems: Qualification Guidance, 2013
8. Supplement 7 Qualification of temperature-controlled storage areas (May, 2015) to WHO Technical Report Series, No. 961, 2011 Annex 9
9. Supplement 8 Temperature Mapping of storage areas (May, 2015) to WHO Technical Report Series, No. 961, 2011 Annex 9

bluebaby0010

GB/T 34399-2017了解下

xiaodong

多谢，很有用

故x原野

还有一个ISPE:Controlled Temperature Chamber Mapping and Monitoring，可以看一下

霾深不知处

《医疗器械冷链（运输、贮存）管理指南》（国家食品药品监督管理总局2016年第154号）

霾深不知处

《医药产品冷链物流温控设施设备验证性能确认技术规范》（GB/T34399—2017）
JJF1101-2003《环境试验设备温度、湿度校准规范》
JJF 1366-2012《温度数据采集仪校准规范》

yzf7399

故x原野 发表于 2021-2-26 12:23
还有一个ISPE:Controlled Temperature Chamber Mapping and Monitoring，可以看一下

这个有第二版的文件吗？

故x原野

yzf7399 发表于 2023-7-20 13:13
这个有第二版的文件吗？

论坛上有，搜索一下