PubMed

沙特FDA智能GxP检查的监管经验反思

PMID：38600418 · 2024-04-10

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期刊Therapeutic innovation & regulatory science

年份2024-04-10

PMID38600418

摘要

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors on site, ensuring efficient utili

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