Regulatory Open Forum

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  • 1.  Mutual Recognition of Health Authority Inspections

    Posted 23-Nov-2020 20:04
    Is anyone aware of recent situations in which the US FDA  has recognized GxP Inspections from EU (or other) countries, particularly, GMP Inspections? Any insights will be helpful.

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    Jethro Ekuta DVM, FRAPS, RAC, PhD
    Audubon PA
    United States
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  • 2.  RE: Mutual Recognition of Health Authority Inspections

    Posted 23-Nov-2020 22:07
    Have you explored MDSAP audit? This comes closet to what you are looking for, that I can think of.

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    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
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    Original Message


  • 3.  RE: Mutual Recognition of Health Authority Inspections

    Posted 23-Nov-2020 23:07
    Thank you, Ritam! I was wondering if there has been any program or individual company's experience where such mutual recognition has occurred with Europe and also involving drugs or biologics.

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    Jethro Ekuta DVM, FRAPS, RAC, PhD
    Audubon PA
    United States
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    Original Message


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