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Formação em contexto de trabalho em laboratório da indústria farmacêutiica
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| 1.83 MB | Adobe PDF |
Advisor(s)
Abstract(s)
O presente estágio curricular foi desenvolvido na equipa de controlo de qualidade (CQ)
da empresa Generis Farmacêutica S.A.
Mais especificamente, o estágio foi desenvolvido no laboratório do controlo de
qualidade, na equipa de produto a granel (PG), no qual se desenvolveram análises
químicas a amostras de diversos medicamentos genéricos, tais como a, claritromicina,
domperidona, lamotrigina, lisinopril, nimesulida e rivastigmina. As técnicas a usar para
cada um dos genéricos depende das especificidades de análise descritos nos
procedimentos analíticos, tendo sido aplicadas técnicas como a medição do pH,
determinação do conteúdo de água por técnica de perda por secagem ou karl Fischer e
doseamento do princípio ativo e substâncias relacionadas, utilizando a cromatografia
líquida de alta performance (high performance liquid chromatography). Todos estes
testes foram realizados de modo a verificar a conformidade dos produtos que se
encontravam no mercado e permitiram ao discente a aquisição de conhecimentos no
âmbito das boas práticas de laboratório.
O presente relatório apresenta as técnicas experimentais utilizadas e os procedimentos,
assim como os resultados obtidos ao longo do estágio curricular.
No capítulo 1, introdução, procede-se a um breve enquadramento do trabalho realizado
no estágio curricular, incluindo os seus objetivos, assim como as atividades
desenvolvidas pelo discente. Ainda neste capítulo, é caraterizado o local onde o estágio
decorreu, como um resumo da sua história e evolução.
No capítulo 2 são apresentados os fundamentos teóricos das técnicas e métodos
aplicados, atividades desenvolvidas e alguns dos princípios ativos (active
pharmaceutical ingredient, API) testados que dão nome aos medicamentos genéricos,
sendo o tema da produção de “genéricos” introduzido. Ainda neste capítulo são
abordados alguns temas da área da indústria, como o controlo de qualidade e as Boas
Práticas de Laboratório (GLP) e Boas Práticas de Fabrico (GMP), para auxiliar na
contextualização do tema de estágio.
No capítulo 3 estão descritos os procedimentos experimentais de cada método utilizado
e respetivos reagentes e equipamentos utilizados. No capítulo 4 estão apresentados os
resultados obtidos ao longo de uma campanha de lamotrigina, em que se analisou dois
lotes, um de 25 mg e outro de 100 mg de potência, havendo a comparação destes
resultados com os obtidos com outros ensaios efetuados a lotes semelhantes.
Finalmente no capítulo 5 e 6 estão sumariadas algumas análises com explicação dos
resultados obtidos e as conclusões que se podem retirar.
This curricular internship was developed in the quality control team (QC) of Generis Farmacêutica S.A. More specifically, the internship was developed in the quality control laboratory, in the bulk product team (PG), in which chemical analyses were developed on samples of several generic drugs, such as clarithromycin, domperidone, lamotrigine, lisinopril, nimesulide and rivastigmine. The techniques to be used for each of the generics depend on the specificities of analysis described in the analytical procedures, and techniques such as pH measurement, determination of water content by drying loss or Karl Fischer technique and dosing of the active ingredient and related substances were applied, using high performance liquid chromatography. All these tests were carried out to verify the conformity of the products that were on the market and allowed the student to acquire knowledge in the context of good laboratory practices. This report presents the experimental techniques used and the procedures, as well as the results obtained throughout the curricular stage. In chapter 1, introduction, a brief framework of the work carried out in the curricular internship is carried out, including its objectives, as well as the activities developed by the student. Still in this chapter, it is characterised the place where the internship took place as well as a summary of its history and evolution. Chapter 2 presents the theoretical foundations of applied techniques and methods, activities developed and some of the active pharmaceutical ingredient (API) tested that give name to generic drugs, being the theme of the production of "generics" introduced. Also, in this chapter are covered some topics in the area of industry, such as quality control and Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), to assist in the contextualization of the internship theme. Chapter 3 describes the experimental procedures of each method used and its reagents and equipment used. Chapter 4 presents the results obtained during a lamotrigine campaign, in which two batches were analysed, one of 25 mg and another of 100 mg of potency, with the comparison of these results with those obtained with other tests carried out in similar batches. Finally, in Chapter 5 and 6, some analyses are presented with an explanation of the results obtained and the conclusions that can be drawn.
This curricular internship was developed in the quality control team (QC) of Generis Farmacêutica S.A. More specifically, the internship was developed in the quality control laboratory, in the bulk product team (PG), in which chemical analyses were developed on samples of several generic drugs, such as clarithromycin, domperidone, lamotrigine, lisinopril, nimesulide and rivastigmine. The techniques to be used for each of the generics depend on the specificities of analysis described in the analytical procedures, and techniques such as pH measurement, determination of water content by drying loss or Karl Fischer technique and dosing of the active ingredient and related substances were applied, using high performance liquid chromatography. All these tests were carried out to verify the conformity of the products that were on the market and allowed the student to acquire knowledge in the context of good laboratory practices. This report presents the experimental techniques used and the procedures, as well as the results obtained throughout the curricular stage. In chapter 1, introduction, a brief framework of the work carried out in the curricular internship is carried out, including its objectives, as well as the activities developed by the student. Still in this chapter, it is characterised the place where the internship took place as well as a summary of its history and evolution. Chapter 2 presents the theoretical foundations of applied techniques and methods, activities developed and some of the active pharmaceutical ingredient (API) tested that give name to generic drugs, being the theme of the production of "generics" introduced. Also, in this chapter are covered some topics in the area of industry, such as quality control and Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), to assist in the contextualization of the internship theme. Chapter 3 describes the experimental procedures of each method used and its reagents and equipment used. Chapter 4 presents the results obtained during a lamotrigine campaign, in which two batches were analysed, one of 25 mg and another of 100 mg of potency, with the comparison of these results with those obtained with other tests carried out in similar batches. Finally, in Chapter 5 and 6, some analyses are presented with an explanation of the results obtained and the conclusions that can be drawn.
Description
Keywords
Controlo de qualidade Genéricos Produto a granel Lamotrigina Boas práticas de laboratório Boas práticas de fabrico Quality control Generics Bulk Lamotrigine Good laboratory practices Good manufacturing practices