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Formação em contexto de trabalho em laboratório da indústria farmacêutica
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Abstract(s)
O presente relatório descreve as atividades desenvolvidas no âmbito do estágio
curricular do Mestrado em Engenharia Biológica e Química na Escola Superior de Tecnologia
do Barreiro e decorreu na Indústria Farmacêutica Generis, S.A., de março a julho de 2021. O
estágio tinha como objetivo, permitir aplicar os conhecimentos teóricos adquiridos, em
contexto real, dando à discente as competências necessárias.
Neste estágio, a discente aprendeu a trabalhar sob as regras de Boas práticas de
fabricação/ Good Manufacturing Practices (GMPs) que descrevem o padrão mínimo de que
um fabricante de medicamentos deve atender nos seus processos de produção e controlo de
qualidade para garantir que são feitos de forma consistente e com a qualidade exigida. A
discente aprendeu também a trabalhar sob as regras de Boas práticas de laboratório/Good
Laboratory Practices (GLP’s) que constituem conjunto de regras e critérios para um sistema
de qualidade relacionado com as condições sob as quais os ensaios que asseguram o
controlo de qualidade de todos os produtos que entram e saem de uma fábrica são realizados,
monitorizados, registados, relatados e arquivados.
Com o objetivo de garantir a qualidade das matérias-primas, foram realizados ensaios
físico-químicos, obtendo-se resultados dentro da especificação ou conformes. Quando esta
condição não se verificou, foram executados os procedimentos adequados a cada ensaio de
forma a ultrapassar ou não, esse resultado fora de especificação.
Os ensaios realizados no laboratório de Controlo de qualidade foram ensaios de
aparência, solubilidade, de identificação por espetroscopia de IV (Infravermelho), ensaios para
determinação do teor de água através dos seguintes métodos: titulação de Karl Fischer e
perda por secagem/loss on drying (LOD), cinzas sulfúricas e totais, cloretos e sulfatos,
titulação por potenciometria e cromatografia líquida de alto desempenho (para quantificar o
princípio ativo e impurezas conhecidas e desconhecidas). O perfil de impureza deve ser
comparado com dados históricos ou do fabricante a fim de detetar alterações no API
resultantes de modificações nas matérias-primas, parâmetros operacionais do equipamento
ou processo de produção.
A discente participou nas atividades de gestão do laboratório que incluiu gestão dos
padrões usados nos vários ensaios, reagentes e amostras. Para além disso, ainda participou
nas atividades de melhoria contínua desenvolvidas pelo laboratório com âmbito na filosofia
Kaizen que visa o aumento de produtividade, otimização dos equipamentos, melhoria da
organização dos espaços e eliminação de desperdícios.
Neste estágio, foram obtidos resultados conformes e não conformes, permitindo a
aquisição de conhecimentos acerca das práticas realizadas em caso de ocorrência de
resultados fora de especificação.
This report describes the activities developed in the curricular internship of the master’s degree in Biological and Chemical Engineering, carried out in Pharmaceutical Industry Generis, S.A from March to June 2021. The aiming of this the internship is to allow the application of the theoretical knowledge acquired, in a real context, giving the student the necessary skills. During this period, the student learned to work in the light of some standard practices, used to ensure a quality system. The Good Manufacturing Practices (GMPs), which aim to describe the minimum standard that a medicine manufacturer must meet in its production processes and the Good Laboratory Practices (GLPs), which aim to describe a set of rules and criteria related to the planning, conduct, monitoring, recording, reporting and archiving of non clinical health studies, as well as the development of tests that ensure the quality control of all products that enter and leave the factory. In order to guarantee the quality of raw materials, physicochemical tests were performed, obtaining results within specification or in compliance. When this condition was not verified, all the correct procedures were followed for each test. The tests performed were, appearance tests, solubility and identification tests by IR spectroscopy (Infra-red). For the determination of the water content, other tests were performed, such as Karl Fischer titration and loss on dry (LOD), sulphuric and total ash, chlorides and sulphates, dosage by potentiometry and high-performance liquid chromatography (HPLC). All the assays were performed as a quantification of the active principle, as well as known and unknown impurities. The impurity profile must be with historical or manufacturer's data in order to detect changes in the API resulting from modifications in the raw materials, equipment operating parameters or production process. Besides the physicochemical tests, the student participated in laboratory management and continuous improvement activities, developed by the laboratory, based on the "Kaizen" philosophy. The activities included the management of the standards used in the various tests, reagents and samples, as well as, the increase of productivity, optimisation of the equipment, improvement of the organisation of the spaces and elimination of waste, respectively. In this internship, compliant and non-compliant results were obtained, enabling the acquisition of knowledge about the standard practices carried out in both situations.
This report describes the activities developed in the curricular internship of the master’s degree in Biological and Chemical Engineering, carried out in Pharmaceutical Industry Generis, S.A from March to June 2021. The aiming of this the internship is to allow the application of the theoretical knowledge acquired, in a real context, giving the student the necessary skills. During this period, the student learned to work in the light of some standard practices, used to ensure a quality system. The Good Manufacturing Practices (GMPs), which aim to describe the minimum standard that a medicine manufacturer must meet in its production processes and the Good Laboratory Practices (GLPs), which aim to describe a set of rules and criteria related to the planning, conduct, monitoring, recording, reporting and archiving of non clinical health studies, as well as the development of tests that ensure the quality control of all products that enter and leave the factory. In order to guarantee the quality of raw materials, physicochemical tests were performed, obtaining results within specification or in compliance. When this condition was not verified, all the correct procedures were followed for each test. The tests performed were, appearance tests, solubility and identification tests by IR spectroscopy (Infra-red). For the determination of the water content, other tests were performed, such as Karl Fischer titration and loss on dry (LOD), sulphuric and total ash, chlorides and sulphates, dosage by potentiometry and high-performance liquid chromatography (HPLC). All the assays were performed as a quantification of the active principle, as well as known and unknown impurities. The impurity profile must be with historical or manufacturer's data in order to detect changes in the API resulting from modifications in the raw materials, equipment operating parameters or production process. Besides the physicochemical tests, the student participated in laboratory management and continuous improvement activities, developed by the laboratory, based on the "Kaizen" philosophy. The activities included the management of the standards used in the various tests, reagents and samples, as well as, the increase of productivity, optimisation of the equipment, improvement of the organisation of the spaces and elimination of waste, respectively. In this internship, compliant and non-compliant results were obtained, enabling the acquisition of knowledge about the standard practices carried out in both situations.
Description
Keywords
Matérias primas Controlo de qualidade Ensaios físico-químicos Raw materials Good manufacturing practices Good laboratory practices Quality control Physicochemical tests