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

Jul 19

Heparin in the FDA's Focus once more: Warning Letter for Chinese Contract Lab ...

Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.

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Jul 19

EMA's updated Implementation Plan for the Introduction of Safety Features ...

The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more about the EMA's implementation plan for safety features.

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Jul 12

FDA Warning Letter for inadequate Batch Record Review ...

The US Food and Drug Administration (FDA recently posted a Warning Letter for a Chinese API manufacturer criticising the quality unit for not exercising its responsibility adequately.

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Jul 12

What is GMP compliant Equipment Design? ...

It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design.

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Jul 07

ECA Visual Inspection Group Chairman appointed to EDQM Expert Group ...

Dr Tobias Posset, Head of Production Support at Roche Diagnostics in Mannheim, Germany and chairman of the ECA Visual Inspection Group, was recently appointed into expert group 12 of the EDQM (European Directorate for the Quality of Medicines & Health Care). Amongst other things, this expert group develops recommendations for the revision of monographs concerning visual inspection. Learn more about Dr Posset's appointment to the EDQM Expert Group.

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Jul 06

How to use Freezers and Refrigerators ...

In a recent post MHRA describes some of the main issues with freezers used by pharmaceutical wholesalers.

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