Press Announcements

New: English translation Aide memoire Qualification and Validation for Inspectors

GMP legislation and guidelines are occasionally not very specific. The pharmaceutical industry is seeking more concrete interpretations, though, especially coming from regulators. Such an example is the guide "Aide memoire Qualification and Validation - Basic Requirements" for inspectors.


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.


GMP Conferences by Topics

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