RESUMO
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.
Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos , Preparações Farmacêuticas/síntese química , Controle de Qualidade , Tecnologia Farmacêutica/legislação & jurisprudência , Fluxo de Trabalho , Qualidade de Produtos para o Consumidor , Contaminação de Medicamentos/legislação & jurisprudência , Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica/instrumentação , Indústria Farmacêutica/métodos , Indústria Farmacêutica/normas , Indústria Farmacêutica/tendências , Contaminação de Equipamentos/legislação & jurisprudência , Contaminação de Equipamentos/prevenção & controle , Falha de Equipamento , Europa (Continente) , Guias como Assunto , Humanos , Legislação de Medicamentos/tendências , Segurança do Paciente , Preparações Farmacêuticas/normas , Tecnologia Farmacêutica/instrumentação , Tecnologia Farmacêutica/métodos , Tecnologia Farmacêutica/normas , Tecnologia Farmacêutica/tendências , Estados Unidos , United States Food and Drug AdministrationRESUMO
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.
RESUMO
Hepatomas thrive in a hypoxic environment resulting in the induction of a cluster of hypoxia related genes. The protein phenotypic expression include hypoxia inducible factor-alpha, prolyl-4-hydroxylase, vascular endothelear growth factor and erythropoietin. The present study was undertaken to determine if human hepatoma cells when cultured for 72 h in the presence of serum under normoxia would maintain their cancerous phenotypic expression of certain hypoxia inducible genes. Our positive results affords an in vitro model system to test hypoxia inhibitors on the expression and the intracellular compartmentalization or the secretion of these hypoxia-inducible proteins.