RESUMO
In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
Assuntos
Benchmarking/normas , Indústria Farmacêutica/normas , Preparações Farmacêuticas/normas , Tecnologia Farmacêutica/normas , Animais , Química Farmacêutica/normas , Preparações de Ação Retardada/normas , Aprovação de Drogas , Indústria Farmacêutica/métodos , Excipientes/química , Excipientes/normas , Humanos , Preparações Farmacêuticas/administração & dosagem , Preparações Farmacêuticas/química , Farmacocinética , Controle de Qualidade , Medição de Risco , Solubilidade , Tecnologia Farmacêutica/métodos , Toxicologia/normas , Estados Unidos , United States Food and Drug AdministrationRESUMO
In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration's Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro-in vivo correlation considerations for transdermal systems.