The National Agency of Sanitary Vigilance of Brazil (ANVISA) confirmed on February 16th that GENOMICA successfully passed the audit that verified compliance with the GMPs (Good Manufacturing Practices). These are required by the government of Brazil to all the companies of the sanitary sector that wants to commercialize its products in this country.
It was during the last week of January when two agency representatives visited the central facilities of the first Spanish in-vitro diagnostic company. During their stay, the work they performed consisted in verifying compliance with GMP legislation. This legislation covers areas such as data recording, staff qualifications, sanitation, cleanliness, equipment checks, process validation and claims management. The GMP system also requires the total documentation of every aspect of the development, production and logistics processes to allow the traceability of a clinical diagnosis product and its withdrawal in case of a problem detected.
Having the certificate of compliance with the GMPs is a great step forward for the diagnostic company, as it has proven to meet the quality standards demanded in markets as important as the United States or China. In this way, and along with the ISO certificates, already in its possession, GENOMICA consolidates its expansion not only in Latin America but in the rest of the world.