Environmental Risk Assessment. ERA reports

In accordance with Article 8(3) of Directive 2001/83/EC, an application for a marketing authorisation for a medicinal product for human use must be accompanied by an Environmental Risk Assessment (ERA). This assessment should be performed according to the European Medicines Agency, following the procedure described in Guideline on the Environmental Risk Assessment of Medicinal Products…

PDE calculation in shared facilities for veterinary medicaments

1. Introduction On June 2016 will be coming into effect for veterinary medicaments EMA’s guideline (EMA/CHMP/CVMP/SWP/169430/2012) already implemented for human medicaments. This document follows the review of chapter 3 and 5 (currently into effect since March 2015), with the purpose of determine a new risk analysis methodology for shared facilities: It is necessary a dedicated…

Estudios Toxicológicos para la definición de valores PDE/ADE en el Análisis de Riesgo para Instalaciones Multiproducto

La compatibilización de productos en las líneas de fabricación y la necesidad de tener o no instalaciones dedicadas para evitar la posibilidad de contaminaciones cruzadas, se plantea como duda constante en el ámbito de la fabricación farmacéutica. Hasta ahora la normativa generaba una serie de malas interpretaciones y de indefiniciones en este sentido, que se…