Modelo de sistema integrado na indústria de insumos farmacêuticos com as boas práticas de fabricação

Abstract

Transformations of the XXI century forced governments and entrepreneurs to make revisions and reconfigurations of institutions and agency of service, changing the concepts of individuals and the companies themselves, for the administration and business management. Accordingly, this work aimed to propose the implementation of an Integrated System of Management for the Industry of Ingredient Pharmaceutical Active, certificate with Good Manufacturing Practice, centralized on quality management systems, environment, social responsibility and health and safety at work, using the standards as guidelines NBR ISO 9001:2000, ISO 14001:2004 NBR, NBR 16001:2004 and OHSAS 18001:2007. The work included a literature review of standards and systems of administrations mentioned uses and experiences, practices with the standards applied to industry. The combination of these items revealed the similarities between the rules, and also to develop a framework for the implementation of GIS in sequential steps with the integration of all standards. It was concluded at the end of work on the feasibility of implementing the GIS in Petrochemicals Pharmaceutical Industries and the interrelationship between the standards studied.