Dear Praveen,
It is difficult to get agreed EU authorities to conduct GMP
inspection of your site, they do GMP inspections taking into the risk
based approach.
Guidance on the occasions (GMP inspection Triggers) when it is
appropriate for competent authorities to conduct inspections at the
premises of manufacturers of active substances used as starting
materials is available at following link.
http://www.emea.europa.eu/Inspections/docs/CoCP/CoCP_APIGMPInspTrigger.pdf
For additional information about GMP inspection, information is
available at following link:
http://www.emea.europa.eu/Inspections/GMPCompproc.html
Hope this will give you insight about EU GMP inspection.
Kind regards.
Lalit Sharma
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