PubMed

Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

PMID: 38600418 · 2024-04-10

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ЖурналTherapeutic innovation & regulatory science

Год2024-04-10

PMID38600418

Аннотация

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 onsite, ensuring efficient utili

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