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Dear Sir,
I like to know what are the important things Brazilian inspectors
looks for in BA/BE centre,
Including both clinical and bioanaylytical lab.
Rgrds,
Dr.Sridhar
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The following message was posted to: PharmPK
Dear Sridhar
You can find in details all informations you are looking for on
this site www.Anvisa.gov.br
http://www.anvisa.gov.br/reblas/bioequivalencia/index.htm
Regards
Eldinaldo Sobral
R&D - EMS SigmaPharma group
Hortolandia-SP
Brasil
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Dear Sir,
Brazilian inspections are done by ANVISA ( Brazilian regulatory
agency) as mencioned by our brazilian fellow.
There are plenty of info in their web site as GLP, and GCP on
bioquivalence guides. You should look for a doc Named : "Roteiro de
inspecao em Centros de Biodisponibilidade/bioequivalencia de
medicamentos". Its is a simple check list of essential points. I don'
t know if there are a english version.
They are quite hard on their inspections. There are a special group
in ANVISA for inspections. You can email this group directly.
Best Regards,
Andre.
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