Processo de regulamentação de um laboratório de biomateriais cerâmicos pelas diretrizes da vigilância sanitária

Abstract

All bioceramics laboratories must be certificated by their competent agencies if it craves for a legal authorization for selling the products. This is this paper scope: to understand the mandatory e complementary standards that a health support department must follow and, by its guidelines, to develop a quality system and their engineering project for the authorization. The brazilian National Health Surveillance Agency (ANVISA) in terms with the Health Ministry (MS) assigns state and municipal secretaries through their Health Surveillance (VISA) inspects all the minimum requirements to assist the official report. For this paper, the management system described was the quality system for manufactures of health products. In it, there is written the Guideline of good practices in manufacturing (BPF) with its adjuvants documents of Standard Operating Procedures (POP) and its records, the Health Solid Waste Management Plan (PGRSS), Equipment Management Plan (PGE), architectural design and the electrical project.