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

Mar 01

Sterile Manufacturer receives Warning Letter from US FDA ...

Following an FDA inspection, a manufacturer of sterile medicinal products in the UK has received a Warning Letter due to serious violations of GMP. As often in such cases, the inspection was preceded by another one where GMP deviations had been observed but to which the company had responded insufficiently. Read more about this Warning Letter here.

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Mar 01

What are the current Rules for Supplier Qualification? ...

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for supplier qualification?

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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 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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Feb 15

First Warning Letter Citation of new FDA Guideline on Contracts ...

After the Food & Drug Admininstration (FDA) published its final Quality Agreements Guidance end of last year, we now find the first citations in Warning Letters.

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