📋 Tender Overview
Compliance with standards, processes and technical procedures is corroborated that guarantees the uniform and controlled production of the reagent kit lots. On its 128th institutional anniversary, the Inspection and Certification Directorate of the General Directorate of Medicines, Supplies and Drugs (Digemid) certified the laboratory of the National Institute of Health (INS) - National Center with Good Manufacturing Practices (GMP). of Production and Strategic Public Health Goods for the manufacture of in vitro diagnostic medical devices: Yellow Fever In Vitro Diagnostic Reagent.
This, within the framework of Law No. 29459, Law on Pharmaceutical Products, Medical Devices and Health Products, the Regulation of Pharmaceutical Establishments approved by Supreme Decree No. 014-2011-SA and amendments, the current health regulations and Reports of the World Health Organization.
Digemid carried out this inspection from May 28 to 31 at the National Center for Production and Strategic Goods of Public Health (CNPB)-Diagnostic Reagents Laboratory and thereby corroborated compliance with standards, processes and technical procedures whose application guarantees uniform production and controlled of each of the lots of the in vitro diagnostic reagent kit, in accordance with quality standards and legally enforceable requirements, making these products available to the population for the benefit of public health.
The Tariki - Yellow Fever IgM diagnostic kit is an in vitro diagnostic test with high sensitivity and specificity for the detection of the antibody that is present in the patients serum.
This certification involved the participation of all personnel from the diagnostic reagent production laboratory, quality control laboratory, quality assurance, metrology, maintenance, CNSP viral metaxenics laboratory, central warehouse and human resources. This certification is valid from May 31, 2024 to May 31, 2029.
