Regulatory Open Forum

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  • 1.  Brazil-GMP

    Posted 01-Feb-2012 03:15

    Dear Forum,

    Will Brazil regs will allow to manufacture Veternary APIs & drug products in the same facility where Human drugs manufacturing takes place.

    Any one of you experienced Brazil GMP inspectors (for Human drugs & APIs) have issued an audit observation for manufacturing veternary medicinal products in the same facility (for APIs or Drug Products).

    Appropriate references to ANVISA legislations/guidelines are much appreciated.

    Cheers,
    Venkat

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    Venkat Reddy Sunkara
    Manager - Regulatory Affairs
    Piramal Healthcare UK Limited
    Northumberland
    United Kingdom
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