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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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

Aug 16

Non-Compliance Report for manufacturing of three Products at Biocon, India ...

The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.

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Aug 16

How to prepare for a Data Integrity Inspection ...

Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.

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Aug 16

Brexit: EMA prioritises Activities ...

The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan.

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Aug 09

FDA Warning Letters and EU Non-Compliance Reports after Inspections of API Plant ...

Just like the FDA's Warning Letters which have been publicly available for many years, the EU non-compliance reports are also accessible now for some time past. Therefore, it's interesting to take a look at those deficiency reports which have been addressed to the same manufacturer. Read here which GMP violations by manufactureres of APIs were found by FDA as well as EU GMP inspectors.

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Aug 09

EMA updates Guidance for Post-Authorization Activities ...

The EMA announced on July 14, 2017, that it has revised three post-authorization activity guidance documents, including type II variations, post-authorization safety studies and changes related to quality aspects. Read more EMA´s updated post-authorizaiton guidelines.

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Aug 09

Missing OOS Trending leads to FDA Warning Letter ...

The India-based pharmaceutical manufacturer Mylan Laboratories received a Warning Letter by the FDA in April 2017. The FDA inspector found that over 70% of initial OOS results were invalidated without sufficient investigation to determine the root cause of those OOS results and that there was no appropriate trending. Get more information about the Mylan Laboratories FDA Warning Letter.

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