A influência do mercado farmacêutico na harmonização dos procedimentos que impactam o ciclo de vida dos produtos
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Data
2021-02-10
Autores
Miwa, Melina Andreia [UNIFESP]
Orientadores
Ferraz, Helena Onishi [UNIFESP]
Tipo
Trabalho de conclusão de curso de graduação
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Resumo
O mercado farmacêutico no Brasil se encontra em constante crescimento e isso se deve a diversos fatores econômicos, tecnológicos e industriais, e, influenciam diretamente a indústria farmacêutica e o paciente. A indústria farmacêutica deve assegurar em cada etapa do ciclo do produto a qualidade, segurança e eficácia de um medicamento. A garantia da qualidade possui grande influência pois é responsável pelo processo de produção e liberação deste medicamento e para isso, faz-se necessário que a indústria farmacêutica esteja em conformidade com as regulações internas e externas estabelecidas por Agências Regulatórias. No Brasil, uma das principais normas que impactam diretamente o ciclo de vida do produto é a que trata das Boas Práticas de Fabricação, descrito na Resolução da Diretoria Colegiada número 301 de 2019, que estabelece as diretrizes para produção de um medicamento até chegar no consumidor. Além disso, também é de extrema importância a etapa pós comercialização, pois os pacientes podem relatar queixas técnicas, e por meio destes relatos é possível encontrar desvios e problemas de qualidade, podendo levar a uma descontinuação ou recolhimento do medicamento. Com as atualizações das resoluções e instruções normativas realizadas pela ANVISA para seguir o ICH e o PIC/S, as indústrias necessitam se adequar aos novos procedimentos, para que assim, o ciclo do produto esteja sob controle e constante melhoria, garantindo um medicamento, eficaz, seguro e com qualidade para o paciente.
Brazil’s pharmaceutical market is constantly growing due to several economic, technological and industrials factors that has a direct influence on the pharmaceutical industry and its patients. Pharmaceutical industry must ensure in each step of the product life cycle, the quality, safety and efficacy of the medicine. Quality assurance is responsible for the manufacturing and release process of the medicine and for that the pharmaceutical industry must be in compliance with internal and external regulations established by the Regulatory Agency. In Brazil, one of the main resolutions that has a direct impact in the product’s life cycle is the Good Manufacturing Practices, described in the Resolution of the Collegiate Board number 301 of 2019, which establishes the guideline for the manufacturing of the medicine, and guarantees the quality, safety and efficacy until it reaches the consumer. Besides that, the post-marketing stage is also extremely important, as patients can report technical complaints and through these reports it is possible to find deviations and quality issues, which may cause a discontinuation or withdrawal of the medicine. Along with the updates of the resolutions and normative instructions carried out by ANVISA to follow ICH and PIC/S, the industries need to adapt to the new procedures, so that the product life cycle is under control and constant improvement, guaranteeing the safety, efficacy and quality of patient’s medicine.
Brazil’s pharmaceutical market is constantly growing due to several economic, technological and industrials factors that has a direct influence on the pharmaceutical industry and its patients. Pharmaceutical industry must ensure in each step of the product life cycle, the quality, safety and efficacy of the medicine. Quality assurance is responsible for the manufacturing and release process of the medicine and for that the pharmaceutical industry must be in compliance with internal and external regulations established by the Regulatory Agency. In Brazil, one of the main resolutions that has a direct impact in the product’s life cycle is the Good Manufacturing Practices, described in the Resolution of the Collegiate Board number 301 of 2019, which establishes the guideline for the manufacturing of the medicine, and guarantees the quality, safety and efficacy until it reaches the consumer. Besides that, the post-marketing stage is also extremely important, as patients can report technical complaints and through these reports it is possible to find deviations and quality issues, which may cause a discontinuation or withdrawal of the medicine. Along with the updates of the resolutions and normative instructions carried out by ANVISA to follow ICH and PIC/S, the industries need to adapt to the new procedures, so that the product life cycle is under control and constant improvement, guaranteeing the safety, efficacy and quality of patient’s medicine.