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Validação de Limpeza na Indústria Farmacêutica
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A indústria farmacêutica é uma indústria de grande dimensão e que exige um elevado grau de qualidade. Na IBERFAR, essa exigência é um requisito obrigatório a todos os níveis. Esta dissertação de mestrado incide na avaliação da limpeza dos equipamentos da produção, um controlo imprescindível, para impedir contaminações cruzadas. O laboratório de controlo da qualidade da IBERFAR tem vindo ao longo dos anos a realizar validações de limpeza com o objetivo de mostrar e verificar que realmente as limpezas efetuadas aos equipamentos e respetivas salas são eficazes, não comprometendo a qualidade dos produtos.
A presente dissertação visa a validação de um método analítico aplicado à validação de limpeza de quatro APIs, através de cromatografia líquida (HPLC). Houve uma importância adicional de elaborar um método analítico para os quatro APIs diferentes de forma a pensar numa futura capacidade de produção mais alargada.
Com base nas áreas dos equipamentos e posologia dos produtos, calculou-se o limite analítico para cada produto "pior-caso".
No que diz respeito à validação do método, foram avaliados os parâmetros: especificidade, exatidão, linearidade, repetibilidade, precisão do sistema, precisão intermédia, teste limite e estabilidade.
Os resultados das validações demonstraram que a gama de trabalho entre 0.25ppm e 125ppm é adequada e que em análises de rotina não é necessário injetar o system suitability apenas é necessário conferir que o sistema está a dar resposta no limite de LOQ (0.25ppm).
The pharmaceutical industry is a large-scale industry that requires a high degree of qual-ity. At IBERFAR, this requirement is a mandatory requirement at all levels. My master's thesis focused on evaluating the cleanliness of production equipment, an essential control to prevent cross-contamination. Over the years, IBERFAR's laboratory quality control has carried out cleaning validations with the aim of showing and verifying that the cleaning carried out on the equipment and respective rooms are effective, not compromising the quality of the products. The present dissertation aims at the validation of an analytical method applied to the cleaning validation of four APIs, through liquid chromatography (HPLC). There was an addi-tional importance of elaborating an analytical method for the four different APIs to think about a wider future production capacity. Based on the areas of equipment and product dosage, the analytical limit was calculated for each "worst case" product. Regarding the validation of the method, the following parameters were evaluated: spec-ificity, accuracy, linearity, repeatability, system precision, intermediate precision, limit test and stability. The validation results showed that the working range between 0.25ppm and 125ppm is adequate and that in routine analysis it is not necessary to inject system suitability, it is only necessary to check that the system is responding within the LOQ limit (0.25ppm).
The pharmaceutical industry is a large-scale industry that requires a high degree of qual-ity. At IBERFAR, this requirement is a mandatory requirement at all levels. My master's thesis focused on evaluating the cleanliness of production equipment, an essential control to prevent cross-contamination. Over the years, IBERFAR's laboratory quality control has carried out cleaning validations with the aim of showing and verifying that the cleaning carried out on the equipment and respective rooms are effective, not compromising the quality of the products. The present dissertation aims at the validation of an analytical method applied to the cleaning validation of four APIs, through liquid chromatography (HPLC). There was an addi-tional importance of elaborating an analytical method for the four different APIs to think about a wider future production capacity. Based on the areas of equipment and product dosage, the analytical limit was calculated for each "worst case" product. Regarding the validation of the method, the following parameters were evaluated: spec-ificity, accuracy, linearity, repeatability, system precision, intermediate precision, limit test and stability. The validation results showed that the working range between 0.25ppm and 125ppm is adequate and that in routine analysis it is not necessary to inject system suitability, it is only necessary to check that the system is responding within the LOQ limit (0.25ppm).
Descrição
Palavras-chave
validação de método analítico validação de limpeza produto pior-caso HPLC Active substance