GMP Compliance in Brazil, PLUS - New Webinar in Portuguese Life Science This week, it's all about Brazil. First, we give a brief summary and some links to some references for Brazilian GMPs. Then, one of our blog readers from Brazil shares his experience with a recent FDA inspection, PLUS - watch our GxP Webinar in Portuguese! Brazil has the largest medical device market in Latin America and has the second largest private health insurance sector in the Americas, second to the US. All companies that manufacture drugs, vaccines and biotechnology in Brazil are inspected by Agência Nacional de Vigilância Sanitária, the National Health Surveillance Agency (ANVISA). Along with complying with Brazilian GMP requirements, companies that ship to the US are inspected by the FDA, which works in collaboration with ANVISA. With the first Brazilian GMP guideline published in 1995, ANVISA has since expanded and updated its guidelines impressively and consistently. Here is a great document from The Food and Drug Law Institute (FDLI): “Brazilian Drug and Medical Device Regulation: A Practical Guide” The link above redirects to the English version of the guide, which is excellent and provides a Quick Reference, a summary of Medical Device regulations from ANVISA, and links to sources like the Ministry of Health. Along with ANVISA, Brazil’s national accreditation body, the National Institute of Metrology, Standardization and Industrial Quality (INMETRO) and National Board of Metrology, Standardization and Industrial Quality (CONMETRO). Here is a list of some important standards and regulatory bodies for Brazil: ABNT—Brazilian Association of Technical Standards ANVISA —Brazilian Health Surveillance Agency CNPJ —National Registry of Legal Entities CONMETRO —National Board of Metrology, Standardization and Industrial Quality INMETRO —National Institute of Metrology, Standardization and Industrial Quality MDIC —Ministry of Development, Industry and Foreign Trade NBR —Registered Brazilian Standards SBAC —Brazilian Compliance Assessment System VISA — Local Health Surveillance Body It's Raining GMP Inspectors in Brazil... From Brazil, QA Validation Coordinator "D" writes: Hi Paul, Thanks for your prompt and comprehensive responses to my email inquiries. It’s much appreciated! To update you, our recent FDA inspection was successful with only a few 483s; none relating to temperature mapping. The inspector asked for temperature mapping information on warehouses, cool rooms, product stability chambers and biological indicator incubation chambers. He checked the calibration data for a number of temperature controlled areas and checked all temperature controlled areas were monitored and alarmed. He also spent a lot of time reviewing the justification for the location of the monitoring temperature and humidity probes, where applicable. We have a Brazilian health authority inspection commencing this week. As they say, when it rains it pours. Kind regards and thanks again for your advice! D
