ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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ECA WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

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Latest GMP News

Sep 14

EMA updates Website on Mutual Recognition Agreements ...

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.

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Sep 14

EMA´s Questions and Answers relating to Flexibility in Manufacturing Conditions ...

The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".

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Sep 13

API starting materials - New Q&A document for ICH Q11 ...

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.

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Sep 13

EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products ...

During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.

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Sep 13

FDA opens Docket on Continuous Manufacturing ...

In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.

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Sep 13

How to become a QP in Europe ...

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.

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