Press Announcements 2019

Although the regulations with regard to qualification and validation are different in the US, in Europe in China and other countries, the core thinking is similar. And what these activities have in common is that they can cost a lot of time and money. A new ECA Guide aims to simplify qualification and validation activities. Special service for participants at the launch conference: get your free download of Jettconsortium templates.

The qualification of equipment has been a regulatory requirement for many years. Although the revision of Annex 15 today allows significantly more flexibility in equipment qualification, it is often still very static and complex. The new ECA Integrated Qualification and Validation Guide will help to change this.

EU GDPs (European Commission of Nov 2013, 2013/C 343/01) require that necessary storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging. What do the real world storing and shipping conditions look like, though?

The ECA Foundation was recently accepted to the European Medicines Agency's List of Stakeholder Organisations. With the listing the EMA confirmed that the ECA fulfills the authority's eligibility criteria.

Sampling of materials is one of the most important processes in pharmaceutical companies. During regulatory GMP Inspections, there are more and more detailed questions today about the amount of samples to be taken, both in Europe and in the US (FDA).