RESUMEN
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.
Asunto(s)
Industria Farmacéutica/legislación & jurisprudencia , Legislación de Medicamentos , Preparaciones Farmacéuticas/síntesis química , Control de Calidad , Tecnología Farmacéutica/legislación & jurisprudencia , Flujo de Trabajo , Seguridad de Productos para el Consumidor , Contaminación de Medicamentos/legislación & jurisprudencia , Contaminación de Medicamentos/prevención & control , Industria Farmacéutica/instrumentación , Industria Farmacéutica/métodos , Industria Farmacéutica/normas , Industria Farmacéutica/tendencias , Contaminación de Equipos/legislación & jurisprudencia , Contaminación de Equipos/prevención & control , Falla de Equipo , Europa (Continente) , Guías como Asunto , Humanos , Legislación de Medicamentos/tendencias , Seguridad del Paciente , Preparaciones Farmacéuticas/normas , Tecnología Farmacéutica/instrumentación , Tecnología Farmacéutica/métodos , Tecnología Farmacéutica/normas , Tecnología Farmacéutica/tendencias , Estados Unidos , United States Food and Drug AdministrationRESUMEN
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.
