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[RegAffairs]Re: QC reporting to production

In Europe it is explicitly stated that QC and
production must be independant of each other. If you
are outside the EEA and supplying that area you must
comply with this requirement. Similarly if you are in
the EEA and (say) you supply external markets e.g. FDA
you are still required to comply with European GMP
requirements.

Rgds

Jim T


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