FDA警告信:设备报警记录未保存,无偏差调查和CAPA

▍来源:GMP办公室    


FDA警告信:设备报警记录未保存,无偏差调查和CAPAFDA警告信:设备报警记录未保存,无偏差调查和CAPA

·         Provide a retrospective review to determine whether potential breaches of your manufacturing parameters had any effect on the quality of products released to the market. 

提供回顾性审查, 以确定潜在的违反生产参数是否对放行到市场的产品质量产生任何影响。


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