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Otimização de processos para garantia da qualidade do produto final numa empresa biotecnológica
| Name: | Description: | Size: | Format: | |
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| 3.97 MB | Adobe PDF |
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Abstract(s)
Os biofármacos representam alguns dos melhores desenvolvimentos da ciência moderna. No
entanto, apesar dos avanços alcançados, a indústria enfrenta um importante desafio na
produção destes medicamentos: a necessidade de garantir a esterilidade do produto final. Este
projeto de dissertação apresenta uma otimização de processos para garantir a qualidade do
produto final numa empresa biotecnológica. Foram abordados dois processos principais: a
qualificação de equipamentos e a análise de esterilidade combinada com a monitorização
ambiental. A qualificação de equipamentos foi otimizada com a elaboração de um formulário
completo de Design Qualification (DQ), baseado em normas da indústria, garantindo a
conformidade com as Good Manufacturing Practices (GMP). Para a análise de esterilidade dos
lotes de lisados de plaquetas humanas (hPL) e monitorização ambiental das áreas onde foram
produzidos estes lotes, foi desenvolvida uma ferramenta em Excel para organizar e visualizar
todos os dados obtidos permitindo a identificação mais clara de padrões de contaminação, e
facilitar a revisão sistemática das fontes de contaminação em vários pontos de amostragem. As
ferramentas implementadas aprimoraram a garantia de esterilidade, contribuindo
significativamente para o controlo de qualidade na produção biofarmacêutica conforme as
GMP.
Biopharmaceuticals represent some of the best developments in modern science. However, despite the advances made, the industry faces an important challenge in the production of these drugs: the need to guarantee the sterility of the final product. This dissertation project presents a process optimization to guarantee the quality of the final product in a biotech company. Two main processes were addressed: equipment qualification and sterility analysis combined with environmental monitoring. Equipment qualification was optimized by drawing up a complete Design Qualification (DQ) form, based on industry standards, guaranteeing compliance with Good Manufacturing Practices (GMP). For the sterility analysis of batches of human platelet lysates (hPL) and environmental monitoring of the areas where these batches were produced, an Excel tool was developed to organize and visualize all the data obtained, allowing for clearer identification of contamination patterns and facilitating the systematic review of contamination sources at various sampling points. The tools implemented improved sterility assurance, making a significant contribution to quality control in GMP-compliant biopharmaceutical production.
Biopharmaceuticals represent some of the best developments in modern science. However, despite the advances made, the industry faces an important challenge in the production of these drugs: the need to guarantee the sterility of the final product. This dissertation project presents a process optimization to guarantee the quality of the final product in a biotech company. Two main processes were addressed: equipment qualification and sterility analysis combined with environmental monitoring. Equipment qualification was optimized by drawing up a complete Design Qualification (DQ) form, based on industry standards, guaranteeing compliance with Good Manufacturing Practices (GMP). For the sterility analysis of batches of human platelet lysates (hPL) and environmental monitoring of the areas where these batches were produced, an Excel tool was developed to organize and visualize all the data obtained, allowing for clearer identification of contamination patterns and facilitating the systematic review of contamination sources at various sampling points. The tools implemented improved sterility assurance, making a significant contribution to quality control in GMP-compliant biopharmaceutical production.
Description
Keywords
Good manufactoring practices Garantia de qualidade Qualificação de equipamentos Esterilidade Quality assurance Equipment qualification Sterility