Gerenciamento de risco para impurezas farmacêuticas
Data
2022-11-28
Autores
Minami, Fabiana 
Orientadores
Oliveira, Débora Cristina de
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
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Resumo
Durante o processo de desenvolvimento e produção de fármacos e produtos acabados existem diversos riscos à qualidade. Esses riscos precisam ser gerenciados e monitorados para serem minimizados ou eliminados e existem diversas metodologias que podem ser utilizadas no processo de avaliação e análise de risco. Algumas ações preventivas, corretivas e melhoria contínua são estabelecidas, visando à diminuição de desvios da qualidade. Um exemplo de risco é a formação de impurezas farmacêuticas, e foi criado o Guia ICH Q3(A), Q3B, Q3C e Q3D para controle de impurezas que são divididas em orgânicas, inorgânicas e solventes residuais, mas há também as que não são identificáveis como as nitrosaminas. A presença de impurezas, mesmo em baixas concentrações, pode levar ao comprometimento da eficácia e segurança do produto, bem como na ocorrência de toxicidade, sendo um dos fatores decisivos na qualidade do produto e na segurança do paciente. Impurezas do tipo nitrosaminas apresentam potencial carcinogênico, fazendo que muitas empresas tivessem seus medicamentos da classe “sartanas” (valsartana, losartana, candesartana, entre outros) retiradas do mercado. A descoberta recente das nitrosaminas é um exemplo da importância desses estudos, destacando a importância dos órgãos reguladores em acompanhar e atuar neste cenário. Portanto, demonstra-se que a tendência para estudar impurezas e gerenciar seus riscos tende a ganhar cada vez mais importância com o passar do tempo e o avanço de novas tecnologias analíticas.
During the process of development and production of drugs and finished products, there are several risks to quality. These risks need to be managed and monitored to be minimized or eliminated and there are several methodologies that can be used in the risk assessment and analysis process. Some preventive, corrective and continuous improvement actions are established, aiming to reduce quality deviations. An example of risk is the formation of pharmaceutical impurities, and the ICH Guide Q3(A), Q3B, Q3C and Q3D was created to control impurities that are divided into organic, inorganic and residual solvents, but there are also those that are not identifiable, like nitrosamines. The presence of impurities, even in low concentrations, can compromise the effectiveness and safety of the product, as well as the occurrence of toxicity, being one of the decisive factors in product quality and patient safety. Impurities such as nitrosamines have carcinogenic potential, causing many companies to have their “sartanas” (valsartan, losartan, candesartan, and others) drugs withdrawn from the market. The recent discovery of nitrosamines is an example of the importance of these studies, highlighting the importance of regulatory bodies in monitoring and acting in this scenario. Therefore, it is shown that the tendency to study impurities and manage their risks tends to gain more and more importance with the passage of time and the advancement of new analytical technologies.
During the process of development and production of drugs and finished products, there are several risks to quality. These risks need to be managed and monitored to be minimized or eliminated and there are several methodologies that can be used in the risk assessment and analysis process. Some preventive, corrective and continuous improvement actions are established, aiming to reduce quality deviations. An example of risk is the formation of pharmaceutical impurities, and the ICH Guide Q3(A), Q3B, Q3C and Q3D was created to control impurities that are divided into organic, inorganic and residual solvents, but there are also those that are not identifiable, like nitrosamines. The presence of impurities, even in low concentrations, can compromise the effectiveness and safety of the product, as well as the occurrence of toxicity, being one of the decisive factors in product quality and patient safety. Impurities such as nitrosamines have carcinogenic potential, causing many companies to have their “sartanas” (valsartan, losartan, candesartan, and others) drugs withdrawn from the market. The recent discovery of nitrosamines is an example of the importance of these studies, highlighting the importance of regulatory bodies in monitoring and acting in this scenario. Therefore, it is shown that the tendency to study impurities and manage their risks tends to gain more and more importance with the passage of time and the advancement of new analytical technologies.