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

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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Feb 15

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

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter <1225> Validation of compendial Methods. Read more about the Validation of Analytical Procedures.

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Feb 09

FDA Guidance for Blood Donations with regard to Ebola Virus published ...

In January the FDA published a guidance for industry on "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".

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Feb 09

FDA Draft Guidance on Labeling of Red Blood Cell Units with Historical Antigen T ...

On 17 January the US FDA published a draft guidance on "Labeling of Red Blood Cell Units with Historical Antigen Typing Results". It is now open for comments.

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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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