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[RegAffairs]Re: EU GMP certification

I understand that there is no GMP certificate issued for API manufacturers.

It is the responsibility in the first instance for the company using 
the material to audit against EU GMPs.  The Qualified Person will 
need to make a suitable statement to the effect that the material is 
manufacture under GMP conditions.

EU competent authorities may choose to inspect the API manufacturing 
site. This will always be done for a 'biological' API.  I am not sure 
of the percentage of other sites that will be inspected by CAs.

In some cases it might be possible for the marketing authorisation 
applicant or the API manufacturer to request such an inspection from 
some of the CAs. However, this will require the submission of a Site 
Master File in advance of the inspection.

I would be pleased to see any additional comments from other Group members.

Regards,

Brian Matthews.


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