Brazil. Pharmaceuticals: Guides on Good Manufacturing Practices

Brazil

The National Health Surveillance Agency (ANVISA) has published new guides to help companies in the pharmaceutical field comply with the good manufacturing practices (GMP) provided for in their legislation. These are the Periodic Product Review Guide (RPP) and the Out-of-Specification Results Investigation Guide (FDE), in force since October 2018, which can be consulted at the following links:

  • http://portal.anvisa.gov.br/documents/10181/3423013/Guia9-2017_v2.pdf/602ca22b-c136-49c0-9231-b31731799201
  • http://portal.anvisa.gov.br/documents/10181/3422944/Guia8_versao2_out2018.pdf/34ebdc1f-802c-4be0-9d93-dcb6f635c19a