Organic impurities

Organic impurities: ICH Q3A AND ICH Q3B

Introduction Identification and quantification of impurities in active ingredients and drugs products is a crucial aspect in pharmaceutical development to ensure the quality and safety of the product. 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…

Pilot extension in EVDAS

The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor the data published in Eudravigilance and to inform the Agency and National Competent Authorities (NCA) of validated signals detected in the database.   On November 22, 2017, it allows to access to the database  (EVDAS) includes in EudraVigilance that allows MAH to…

Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a challenge for the pharmaceutical industry. Based on the document ‘Implementation strategy of ICH Q3D guideline’ (EMA/CHMP/QWP/115498/2017 – Committee for Medicinal Products for Human use (CHMP), there are two different approaches to risk management of elemental impurities…

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…

SALUD, DEPORTE Y BIENESTAR

Más allá de la definición (repetidamente renovada) que la propia Organización Mundial de la Salud hace sobre ella (estado de pleno bienestar físico, mental y social, y no solamente la ausencia de enfermedad), parecería bien sencillo asociar los conceptos de salud y deporte con el de bienestar. Por subjetivo que sea este último y pudiera…

Brexit: Regulatory Impact

Introduction On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union, a process known as “Brexit”. As a consequence of this, the European Medicines Agency (EMA) relocated from London to Amsterdam, and the United Kingdom will become a “third country” starting 30 March 2019.  …