Extractable Impurities identification

How to Identify extractables and leachables Impurities

The packaging materials for pharmaceutical products are designed to protect them from environmental contamination. However, the presence of extractables and leachables originating from these packing materials in the pharmaceutical product can lead to a change in its composition that can in turn modify its therapeutic action, its organoleptic properties or its stability. Furthermore, the extractables…

Identification and quantification of impurities: a crucial aspect in pharmaceutical development

Introduction Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient is considered an impurity. The presence of impurities, even in small amounts, may influence the efficacy and / or safety of the drug, hence the importance of their toxicological assessment and control. Impurities…

RMP changes to GVP Module V- A doorway to better risk-oriented, scientifically valuable RMPs

On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2), together with a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev 2). During the transition period, RMPs prepared according…

Oportunidades de Negocio en el sector Ciencias de la Salud*

  En los momentos de crisis, sólo la imaginación es más importante que el conocimiento.” Albert Einstein   Las empresas farmacéuticas y biotecnológicas compiten para conseguir posiciones estratégicas poderosas en los mercados grandes, atractivos, con un rápido crecimiento y una fuerte competencia. El crecimiento de la población, su envejecimiento, la conversión de enfermedades terminales en…