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 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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Feb 15

Revised USP Chapter <1225> "Validation of Compendial Methods" approved ...

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter Validation of compendial Methods. Read more about the Validation of Analytical Procedures.

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Feb 15

Inspection Findings in Supplier Qualification and Contracting ...

Supplier Qualification and Contracts are a hot topic in inspections. Some detailed examples of observations were published recently by the U.K. authority MHRA.

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Feb 15

Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Par ...

As a consequence of significant GMP violations, the American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Read more about the details concerning data integrity issues listed in the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd. 

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