Asunto(s)
Química Farmacéutica/normas , Congresos como Asunto/normas , Industria Farmacéutica/normas , Control de Calidad , United States Food and Drug Administration/normas , Química Farmacéutica/tendencias , Congresos como Asunto/tendencias , Industria Farmacéutica/tendencias , Humanos , Estados Unidos , United States Food and Drug Administration/tendenciasRESUMEN
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.
Asunto(s)
Diseño de Fármacos , Preparaciones Farmacéuticas/normas , Aprobación de Drogas , Humanos , Control de Calidad , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Visible particulates (VP) are one subclass of defects seen during the final visual inspection of parenteral products and are currently one of the top ten reasons for recalls 1,2. The risk posed by particles is still unclear with limited experience reported in humans but remains an important consideration during the manufacture and use of parenteral products. From the experimental and clinical knowledge of the distribution of particulate matter in the body, clinical complications would include events occurring around parenteral administration e.g., as a result of mechanical pulmonary artery obstruction and injection site reaction, or sub-acute or chronic events e.g., granuloma. The challenge is to better understand the implication for patients of single vials with VP and align the risk with the probabilistic detection process used by manufacturers for accept/reject decisions of individual units of product.
