Dear All,
Thanks for your responses. I agree with Brian that it is the
responsibility in the first instance for the company using the
material to audit against EU GMPs.
We have a request from a reputed pharma company to "request an
inspection of the facility by a competent national authority in order
to certify the GMP status", we also have similar request from other
European customers who want the GMP certificate from some EU national
agencies to apply for a MAV.
EDQM inspects only if we apply for a CEP. But how do we get a GMP
certificate in general for the facility only by requesting the agency
either EMEA / or national agencies to inspect us independent of any
MAA, DMF, CEP.
Regards,
Kirti
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Kirti Rawal
kirti@dishmangroup.com
Dishman Pharmaceuticals and Chemicals Limited
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