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

May 24

FDA´s Office of Regulatory Affairs restructured ...

FDA´s main task is to protect public health. Therefore, the FDA has to keep pace with new developments in sciences and globalisation. To keep this pace the FDA has set up an alignment programme.

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May 24

FDA Import Alert for inadequate Inspection Management ...

An Indian drug manufacturing facility receives a Warning Letter and an Import Alert because FDA investigators were detained from doing their job properly.

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May 24

USP Draft General Chapters on Plastic Components and Systems Used in the Manufac ...

The USP proposes two new general chapters <665> and <1665> to address the qualification of polymeric components used in the manufacture of pharmaceutical and biopharmaceutical APIs and drug products. Chapter <665> was previously published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3>. Read more about the proposals for Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products and Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.

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May 24

Recent FDA Warning Letter: Issues with Monitoring of microbiological Environment ...

Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.

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May 17

Brexit: U.K. will become 'Third Country' according to EU Statement ...

The EU Commission and EMA made a clear statement that after 30 March 2019, the Unit Kingdom will become a 'third country'. Both expect marketing authorisation holders to prepare accordingly.

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May 17

European authorities' viewpoint on validation deficiencies ...

An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.

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