O PROCESSO DE CERTIFICAÇÃO DE BOAS PRÁTICAS DE FABRICAÇÃO EM UMA EMPRESA DE PRODUTOS PARA A SAÚDE NA CIDADE DE SÃO PAULO – ESTUDO DE CASO

Abstract

This article is mainly focused on developing aroadmap in order to describe the complexity ofimplementation and certification of Good ManufacturingPractices (GMP), according to RDC-59/00 - ANVISA. Thisstandard is applicable only to companies - manufacturers,importers and distributors - products for health, which arethose used in offices, clinics, hospitals and other healthservices, such as for pressure vessels, pots of universalcollection, equipment for radiography and tomographyequipment. According to current legislation this work aimsto demonstrate the complexity of a process of GMPcertification, the bureaucracy and the difficulties that manycompanies have to maintain a business devoted to themanufacturing of healthcare products.Index Terms ⎯  Brazilian Bureaus of Sanitary Monitoring,GMP, Health products, RDC-59 norms, certification.