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

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Latest GMP News

Feb 22

WFI obtained by non-distillation methods - What are the Next Steps? ...

The European Pharmacopoeia's revised monograph 169 on water for injection (WFI) will become effective by the 1st of April 2017. For the first time in Europe, a monograph will allow the production of WFI with other methods than distillation. But there are still unanswered questions, e.g. how to deal with HPW systems which have been already producing water with WFI quality. Read more about the revision of the Monograph on WFI.

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Feb 22

FDAs Draft Guidances of Compounding and Repackaging of Radiopharmaceuticals ...

The FDA published two draft gidelines on their current thinking on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies as well as by outsourcing facilities.

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Feb 22

Draft USP Chapter <671> Containers - Performance Testing ...

A draft version of general chapter Containers—Performance Testing has been recently published in the Pharmacopeial Forum - and is open for comments until end of March.

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Feb 22

Warning Letter and Import Alert for Chinese Manufacturer ...

During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations  Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.

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Feb 15

New FDA Guidance: When is a Product considered "Suspect"? ...

In December 2016, the FDA published a guideline setting specific requirements on how trading partners can identify suspect products and inform the FDA about them. Read more information about FDA's current document "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" here in this News.

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Feb 15

Counterfeit Medicines in the Legal Supply Chain ...

The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls - e.g. due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Read more about it here.

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