ANVISA officially opens the door for MDSAP Audits

With a tiny amendment in the regulation the audit performed by ANVISA is no more the sole GMP inspection acting as a prerequisite for the product registration in Brazil. Manufacturers can also provide evidence of GMP compliance by successfully following the MDSAP program.

For further details refer to RDC 183:2017

Furthermore the ANVISA keeps publishing those Auditing Organizations (AO) that were recognized for performing the MDSAP audit.

The most current list is available on the FDA Website for the MDSAP program.

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