Press Announcements

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.

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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.

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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?

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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.

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ECA GMP News Service on Twitter

Get the latest GMP trends quickly and easily anytime and anywhere - with the ECA's service on Twitter.

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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).

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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.

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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.

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GMP Conferences by Topics

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