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

Feb 08

Quality Metrics and the Way to Continual Improvement and Business Continuity ...

To remain 'regulatory compliant' and to ensure the continuity of product supply, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics and Performance Indicators.

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Feb 08

What are the current GMP Inspection Initiatives? ...

The ICMRA has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and FDA.

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Feb 08

Explosion of an API Manufacturing Site: Supply of Medicinal Products Endangered ...

In October 2016, a facility of the company Qilu for manufacturing the antibiotic Piperacillin exploded. This accident at one production site has led to serious consequences in Germany. Read more here about the reasons and consequences of the supply shortages.

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Feb 08

Written Confirmations - Does the procedure work as it should? ...

Since January 2013 all imported APIs need to be accompanied by a so called "Written Confirmation" (except a few countries with equivalent GMP standards like the US and Switzerland) which should confirm that the manufacturing site is working under GMP (ICH Q7). But how much does the system help to improve quality of APIs. An investigation of written confirmations issued by the Indian Authorities reveals some surprises. Read more about the Written Confirmations for APIs.

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Feb 01

Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the ...

The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. Read more here about the changes in the European Pharmacopoeia regarding the control of elemental impurities in different pharmacopoeia monographs.

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Feb 01

European Authority's Inspection Findings in the Area Validation/Qualification ...

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

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