Good manufacturing practices of medicines and their determinants
DOI:
https://doi.org/10.22239/2317-269X.00918Keywords:
Good Manufacturing Practices, Health Care Coordination and Monitoring, Government Regulation, Pharmaceutical Technology, Drug Industry, Sanitary SurveillanceAbstract
Good Manufacturing Practices (GMP) ensure that drugs are consistently produced and controlled according to previously established quality standards. They are designed to manage and minimize the inherent risks involved in the manufacture of drugs in order to ensure the quality, efficacy and safety of the finished product. Since their inception as we know them today, several versions have taken place in Brazil and worldwide. This work proposes to analyze GMP, through the analysis of the content of Brazilian regulatory frameworks, identifying the determinants that can explain their evolution over the last decades. GMP were broken down into topics and subtopics and their versions present in the five regulatory frameworks studied were evaluated. It was possible to verify, in the evolution of drug manufacturing requirements, the interference of technological innovation and the influence of new practices related to quality, identifying the GMP transformation dynamics.Downloads
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