FDA如何评估和确保合规性

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声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 最近莫老大哥凭着“483”又火了一把，而且ORA,CDER,CVM,CDRH在6月份联合修订并发布了一份关于在FDA检查时，企业如果延误，否认，限制或拒绝行为时的指南： 。不得不让人产生一点联想。 因FDA在国际上的影响力和重要性，让我们一起来看一下FDA时如何评估和确保合规的。 CGMP Inspections  CGMP 检查 For postmarket inspections, each year FDA prioritizes its surveillance inspections using a risk-based model. The frequency at which a facility is prioritized for inspection is based on multiple risk factors (although being selected for an inspection does not necessarily signal a quality issue). Additionally, FDA can inspect facilities on a for-cause basis if information warrants it. 对于 ………………………………