摘要
依据密闭空间温湿度的额定偏差评价标准函数,按照药品经营质量管理规范要求,设计了药品稳定性试验箱温湿度参数的验证方案,提出合理的测点布置数量、样品摆放方法和设备验证技术指标;通过实际的开关门和通断电验证试验,总结了验证过程中的重点和难点问题的应对方式和实践方法,为药品稳定性试验箱的温湿度参数验证和药品稳定性试验提供了参考价值。
Based on the standard function for evaluating the rated deviation of temperature and humidity in enclosed spaces,and in accordance with the requirements of the Good Manufacturing Practice for Drugs,this paper elaborates on the validation of temperature and humidity parameters for drug stability test chambers from multiple aspects,including equipment validation technical indicators,measurement point layout,validation content items,validation results,and summary evaluation.Combined with actual validation experiments,precautions and practical methods during the validation process are provided.
作者
石良喜
张贺丽
潘旭枫
Shi Liangxi;Zhang Heli;Pan Xufeng(Guangzhou Institute of Metrology and Testing Technology)
出处
《上海计量测试》
2026年第1期32-37,共6页
Shanghai Measurement and Testing
关键词
药品稳定性试验箱
温湿度分布
验证
试验
drug stability test chamber
distribution of temperature and humidity
validation
test
