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Abstract(s)
Para assegurar a qualidade de um produto farmacêutico é necessário que os diferentes departamentos na Indústria Farmacêutica, nomeadamente o departamento da Garantia da Qualidade, garantam a conformidade de todas as fases ao longo dos processos de fabrico. Todas as etapas desde a aquisição da matéria-prima até ao lançamento do produto final para o mercado, passando pelas análises físico-químicas, microbiológicas e todos os equipamentos intervenientes devem estar de acordo com as Boas Práticas de Fabrico, com as diversas farmacopeias, entre outras legislações em vigor. O projeto foi concretizado no departamento da Garantia da Qualidade da empresa Iberfar, Indústria Farmacêutica SA, mais propriamente, no âmbito da qualificação de equipamentos. O objetivo do presente trabalho final consiste na apresentação de documentos elaborados no decorrer da qualificação do novo equipamento de cromatografia em fase gasosa e do sistema de fornecimento de gases que lhe está associado, em conformidade com as referidas exigências regulamentares. Este novo equipamento visa aumentar a rentabilidade da empresa e diminuir o tempo de entrega de resultados ao cliente, aumentando a sua satisfação. Deste modo foi realizada, por fim, uma análise financeira que demonstra a poupança anual com a aquisição do novo equipamento, bem como o período que irá ser necessário para recuperar o valor do investimento inicial da compra.
To ensure the quality of a pharmaceutical product it is necessary that the different departments in the Pharmaceutical Industry, namely the Quality Assurance department, assure the conformity of all phases throughout the manufacturing processes All stages from the acquisition of raw materials to the release of the final product on the market, including chemical and microbiological analyses and all intervening equipment must be in conformity with Good Manufacturing Practices, the various pharmacopoeias, as well as other current legislation. The project was executed in the Quality Assurance department of the company Iberfar, Indústria Farmacêutica SA, more specifically, in the area of equipment qualification. The purpose of this final work is to provide the documents elaborated during the qualification of the new gas chromatography equipment and the associated gas supply system, in compliance with the aforementioned regulatory requirements. This new equipment is intended to increase the company's efficiency and reduce the time it requires to deliver results to the client, increasing the satisfaction of the client. In this way, a financial analysis was carried out to demonstrate the annual financial saving with the acquisition of the new equipment, as well as the period that will be necessary to recover the value of the initial purchase investment.
To ensure the quality of a pharmaceutical product it is necessary that the different departments in the Pharmaceutical Industry, namely the Quality Assurance department, assure the conformity of all phases throughout the manufacturing processes All stages from the acquisition of raw materials to the release of the final product on the market, including chemical and microbiological analyses and all intervening equipment must be in conformity with Good Manufacturing Practices, the various pharmacopoeias, as well as other current legislation. The project was executed in the Quality Assurance department of the company Iberfar, Indústria Farmacêutica SA, more specifically, in the area of equipment qualification. The purpose of this final work is to provide the documents elaborated during the qualification of the new gas chromatography equipment and the associated gas supply system, in compliance with the aforementioned regulatory requirements. This new equipment is intended to increase the company's efficiency and reduce the time it requires to deliver results to the client, increasing the satisfaction of the client. In this way, a financial analysis was carried out to demonstrate the annual financial saving with the acquisition of the new equipment, as well as the period that will be necessary to recover the value of the initial purchase investment.
Description
Trabalho de Projeto de natureza científica para obtenção do grau de Mestre em Engenharia da Qualidade e Ambiente
Keywords
Boas práticas de fabrico Indústria farmacêutica Garantia da qualidade Equipamentos Qualificação Good manufacturing practice Pharmaceutical industry Quality assurance Equipment Qualification
Citation
ANJOS, Andreia Sofia Teodoro dos – Qualificação de um cromatógrafo em fase gasosa na indústria farmacêutica. Lisboa: Instituto Superior de Engenharia de Lisboa, 2022. Dissertação de Mestrado.
Publisher
Instituto Superior de Engenharia de Lisboa