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AAPS PharmSciTech ; 16(5): 993-1001, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26288941

RESUMO

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.


Assuntos
Produtos Biológicos/síntese química , Equipamentos Descartáveis , Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica , Gestão de Riscos , Tecnologia Farmacêutica/instrumentação , Produtos Biológicos/efeitos adversos , Produtos Biológicos/normas , Produtos Biológicos/provisão & distribuição , Qualidade de Produtos para o Consumidor , Equipamentos Descartáveis/normas , Indústria Farmacêutica/normas , Humanos , Segurança do Paciente , Controle de Qualidade , Medição de Risco , Fatores de Risco , Gestão de Riscos/normas , Tecnologia Farmacêutica/normas
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