Avaliação continuada de processos utilizando métodos bootstrap
DOI:
https://doi.org/10.35685/4r0esr91Schlagwörter:
Reamostragem, Indústria farmacêutica, Controle de processos, Amostras pequenasAbstract
A verificação contínua de processo constitui estratégia fundamental para o monitoramento sistemático da qualidade em processos produtivos farmacêuticos. O presente estudo explorou a aplicação de métodos bootstrap para a definição de limites de controle da dureza média de comprimidos genéricos, utilizando dados históricos de oito lotes com baixa disponibilidade amostral. Realizou-se uma análise descritiva exploratória, elaboração de gráfico boxplot e aplicação do teste de normalidade de Anderson-Darling. Construíram-se cartas de controle para a média e amplitude, comparando os métodos tradicionais e a abordagem bootstrap. Os resultados indicaram uma distribuição aproximadamente simétrica e dispersão moderada da dureza média, com a identificação de um valor atípico. Verificou-se que os limites calculados via bootstrap foram mais amplos e apresentaram maior sensibilidade para identificar pontos fora de controle em comparação aos métodos clássicos, evidenciando robustez em cenários de amostragem limitada. Conclui-se que a integração do método bootstrap à análise estatística tradicional fortalece o monitoramento da qualidade, proporcionando uma avaliação mais realista e eficaz da estabilidade do processo de compressão, especialmente para medicamentos com baixa demanda produtiva.
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