Polymeric materials in manufacturing processes: a new theat of extractable impurities

1. Introduction In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic components in many pharmaceutical and biotechnological manufacturing processes. The range of polymeric materials available in the industry is very broad and materials have been developed with very different structural properties depending on the desired application. Some…

Nuevas responsabilidades del Director Técnico (Anexo 16). Análisis de Riesgo

Nuevas responsabilidades del Director Técnico (Anexo 16). Sesión AEFI/COFM y videoconferencia CGCF. Recientemente, junto a Isabel Alcalde Socia del Bufet, de Abogados Amat y Vidal-Quadras, tuve ocasión de exponer en 2 sesiones las novedades del anexo 16 y las responsabilidades administrativas, civiles y penales que asume el Director Técnico. La primera sesión, desarrollada el 16…