Press Announcements 2019

European GDP Association launches newly designed website

The European GDP Association has launched its newly designed website to provide members and those interested with information and practical tools. The website now comes in a cleaner design - helping visitors to find information faster and easier. 


Urgent ECA/APIC/European QP Association Meeting on Nitrosamine Impurities announced

Since EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer in June 2018, more and more cases of drug substance and drug product batches contaminated with Nitrosamines have come up. Consequently there is a need to discuss all relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products


The new ubiquitous term in aseptic manufacturing - Contamination Control Strategy

With the publication of the draft revision of Annex 1, a term emerges that has not previously been present in this intensity in the guideline - "Contamination Control Strategy".


Up-to-date Information on Nitrosamine Contamination in APIs at the APIC Conference

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Medicines Agency (EMA) stated that they would set up a number of measures to deal with the further nitrosamine issues that recently have been emerging.


How to save Time and Money in international Qualification and Validation

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.


How to document a Product Transfer? Get Example Templates for free!

As a participant of the GMP training course "Product Transfer" you will receive a USB-Stick with example documents, templates and guidelines for site change projects.


Flexible equipment qualification requires less time and reduces costs

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.


Stability Studies supporting the Shipping/Distribution of Pharmaceuticals/Biopharmaceuticals

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?


ECA Foundation added to EMA List of Stakeholder Organisations

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.


How to Develop a Sampling Plan Which Meets EU and FDA GMP Requirements?

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).


Current Activities of the EQPA

The European QP Association is quite active in supporting its members. Find out what the EQPA has achieved in the last six months.


ECA Visual Inspection Group - Update

The ECA Visual Inspection Group has been founded in 2013 by representatives of the pharmaceutical industry and GMP authorities as part of the ECA Foundation. Learn more about the group and its objectives.


GMP Conferences by Topics

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