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Publicação
Controlo de qualidade de uma farmacĂȘutica
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O Controlo de Qualidade (CQ) Ă© altamente importante na indĂșstria farmacĂȘutica para garantir a qualidade, segurança, eficĂĄcia e credibilidade dos medicamentos aos consumidores e colaboradores. Este envolve atividades e tĂ©cnicas para inspecionar e testar os produtos finais para satisfazer os padrĂ”es de qualidade, mas tambĂ©m envolve garantir a qualidade de um produto ou serviço ao longo do seu ciclo de vida. Tem o objetivo de verificar e testar os vĂĄrios medicamentos nos diversos passos de produção para garantir que cada produto seja de alta qualidade. Este sistema necessita de seguir as Boas PrĂĄticas de LaboratĂłrio (BPL), assim como as normas regulamentares e de qualidade exigidas no setor farmacĂȘutico. Este estĂĄgio acadĂ©mico foi efetuado na Hikma FarmacĂȘutica (Portugal) S.A., na fĂĄbrica 4 (Hikma 4), localizada na Terrugem, Sintra. O objetivo do estĂĄgio curricular foi o desenvolvimento de atividades na ĂĄrea de Controlo de Qualidade e GestĂŁo de Lotes de vĂĄrios produtos injetĂĄveis. Inicialmente foram realizados a verificação, receção, controlo e arrumação de vĂĄrios padrĂ”es e o descarte de amostras (finais e de estabilidade) previamente analisadas. Efetuou-se a separação de padrĂ”es de trabalho (working standards) em diferentes vials opacos de pequenas dimensĂ”es. Foram fechados vĂĄrios livros de registo (logbooks) apĂłs estes se encontrarem preenchidos, tendo-se realizado uma verificação final antes do seu fecho. Realizaram-se anĂĄlises quĂmicas e fĂsicas, com o objetivo de determinar a percentagem de ĂĄgua, pH, aparĂȘncia e espectro Ultravioleta (UV), e anĂĄlises de Cromatografia em Camada Fina (TLC) de vĂĄrias amostras, com o objetivo de identificar e quantificar possĂveis impurezas presentes nos medicamentos. Todas as anĂĄlises realizadas deram origem aos resultados esperados (conforme).
Quality Control (QC) is highly important in the pharmaceutical industry to ensure the quality, safety, efficacy, and credibility of medicines for consumers and employees. This involves activities and techniques to inspect and test final products to meet quality standards, but it also involves ensuring the quality of a product or service throughout its life cycle. Its purpose is to verify and test various medicines at different stages of production to ensure that each product is of high quality. This system must comply with Good Laboratory Practice (GLP), as well as the regulatory and quality standards required in the pharmaceutical sector. This academic internship was carried out at Hikma FarmacĂȘutica (Portugal) S.A., at factory 4 (Hikma 4), located in Terrugem, Sintra. The objective of the curricular internship was to develop activities in the area of Quality Control and Batch Management of various injectable products. Initially, the verification, reception, control, and storage of various standards and the disposal of previously analyzed samples (final and stability) were carried out. Working standards were separated into different small opaque vials. Several logbooks were closed after they were filled in, and a final check was carried out before closing them. Chemical and physic analyses were performed to determine the percentage of water, pH, appearance, and ultraviolet (UV) spectrum, and Thin Layer Chromatography (TLC) analyses of various samples were performed to identify and quantify possible impurities present in the drugs. All analyses performed obtained the expected results (compliant).
Quality Control (QC) is highly important in the pharmaceutical industry to ensure the quality, safety, efficacy, and credibility of medicines for consumers and employees. This involves activities and techniques to inspect and test final products to meet quality standards, but it also involves ensuring the quality of a product or service throughout its life cycle. Its purpose is to verify and test various medicines at different stages of production to ensure that each product is of high quality. This system must comply with Good Laboratory Practice (GLP), as well as the regulatory and quality standards required in the pharmaceutical sector. This academic internship was carried out at Hikma FarmacĂȘutica (Portugal) S.A., at factory 4 (Hikma 4), located in Terrugem, Sintra. The objective of the curricular internship was to develop activities in the area of Quality Control and Batch Management of various injectable products. Initially, the verification, reception, control, and storage of various standards and the disposal of previously analyzed samples (final and stability) were carried out. Working standards were separated into different small opaque vials. Several logbooks were closed after they were filled in, and a final check was carried out before closing them. Chemical and physic analyses were performed to determine the percentage of water, pH, appearance, and ultraviolet (UV) spectrum, and Thin Layer Chromatography (TLC) analyses of various samples were performed to identify and quantify possible impurities present in the drugs. All analyses performed obtained the expected results (compliant).
Descrição
Palavras-chave
Controlo de qualidade IndĂșstria farmacĂȘutica Medicamentos Boas prĂĄticas de laboratĂłrio Segurança Quality control Pharmaceutical industry Medicines Good Laboratory Practice Safety