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Abstract(s)
O Controlo da Qualidade (CQ) na indústria farmacêutica e biofarmacêutica é crucial para a garantia da segurança, eficácia e qualidade de produtos medicinais, sendo altamente regulamentado na União Europeia pelas Boas Práticas de Fabrico. A realização de análises qualitativas e quantitativas de substâncias presentes num produto medicinal é uma parte fundamental do CQ, permitindo verificar se este se encontra em conformidade com os requisitos de qualidade definidos. O presente relatório apresenta o trabalho desenvolvido na empresa Paralab durante o período de estágio, em que houve a oportunidade de participar em atividades relacionadas com o CQ na indústria farmacêutica. Foi realizado o desenvolvimento, validação e transferência de um método analítico para a quantificação de etanol num produto farmacêutico, através da técnica de análise de Cromatografia Gasosa (CG) com amostragem por headspace. Adicionalmente, foi realizada a qualificação do equipamento de CG e a atualização de um plano de verificação e calibração dos Equipamentos de Medição e Monitorização (EMM) da empresa. A experiência de estágio proporcionou uma compreensão prática e teórica abrangente do CQ na indústria farmacêutica e biofarmacêutica, desde a conformidade com as normas e diretrizes das Boas Práticas de Fabrico até à aplicação prática das técnicas analíticas no desenvolvimento e validação de um método analítico, reforçando a importância destas etapas na garantia da qualidade dos produtos farmacêuticos.
Quality Control (QC) in the pharmaceutical and biopharmaceutical industry is essential to ensure the safety, efficacy, and quality of medicinal products and is highly regulated in the European Union by Good Manufacturing Practices. Conducting qualitative and quantitative analyses of substances found in medicinal products is a fundamental component of QC, ensuring compliance with specified quality standards. This report presents the work carried out at Paralab during the internship that provided the opportunity to engage in QC related activities in the pharmaceutical industry. The development, validation, and transfer of an analytical method for quantifying ethanol in a pharmaceutical product were undertaken, utilizing Gas Chromatography (GC) with headspace sampling technique. Additionally, the qualification of the GC equipment and the update of a verification and calibration plan for the company's Measurement and Monitoring Equipment were performed. The internship experience offered a comprehensive practical and theoretical understanding of QC in the pharmaceutical and biopharmaceutical industry, encompassing adherence to Good Manufacturing Practices guidelines and the practical application of analytical techniques in the development and validation of an analytical method, reinforcing the significance of these stages in ensuring the quality of pharmaceutical products.
Quality Control (QC) in the pharmaceutical and biopharmaceutical industry is essential to ensure the safety, efficacy, and quality of medicinal products and is highly regulated in the European Union by Good Manufacturing Practices. Conducting qualitative and quantitative analyses of substances found in medicinal products is a fundamental component of QC, ensuring compliance with specified quality standards. This report presents the work carried out at Paralab during the internship that provided the opportunity to engage in QC related activities in the pharmaceutical industry. The development, validation, and transfer of an analytical method for quantifying ethanol in a pharmaceutical product were undertaken, utilizing Gas Chromatography (GC) with headspace sampling technique. Additionally, the qualification of the GC equipment and the update of a verification and calibration plan for the company's Measurement and Monitoring Equipment were performed. The internship experience offered a comprehensive practical and theoretical understanding of QC in the pharmaceutical and biopharmaceutical industry, encompassing adherence to Good Manufacturing Practices guidelines and the practical application of analytical techniques in the development and validation of an analytical method, reinforcing the significance of these stages in ensuring the quality of pharmaceutical products.
Description
Keywords
Boas práticas de fabrico Controlo da qualidade Desenvolvimento Validação Good manufacturing practices Quality control Development Validation