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[RegAffairs]RE: EU GMP certification

Hello Kirti,

What is the purpose to get EUGMP certification? There are number of MRAs in
place where different authorities respect other's inspection records/data.

There is no direct procedure, where in you apply for purpose and you get an
inspection.

One way is to apply for CEP. However here it is not mandatory for authority
to inspect but as the trend shows authority may inspect your firm.

Second way is to file DMF for a customer who files MAA. In turn respective
authority may inspect depending on priorities.

Best Regards,
Ketan Agravat


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