Brazil's GMP Guideline Available in English

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

In a globalised world, it is interesting to consider pharmaceutical markets outside the classical regions Europe, USA and Japan like, for example, South America. Conversely, this means that the monitoring authority in the country which imports medicinal products is able to perform a GMP inspection of the exporter.

The Brazilian monitoring authority ANVISA is definitely known in Europe. Of course, these authorities have their own GMP inspection requirements. In this respect, having the inspection documents in English is useful. The ANVISA also provides its GMP requirements in English which you can find here.