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.

Read more

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.

Read more

ECA WebAPP – standing out, outstanding

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

Read more

Latest GMP News

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.

More

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.

More

May 17

USP Draft Chapters on Glass Containers <660> and <1660> ...

Revised USP general chapters <660> and <1660> have been published for comment in the Pharmacopeial Forum. Read more about the drafts for Containers-Glass and Evaluation of the Inner Surface Durability of Glass Containers.

More

May 17

FDA Warning Letter: Visible Particles and Visual Inspection ...

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.

More

May 17

Warning Letter for Brazilian Manufacturer of Antibiotics ...

In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.

More

May 11

New USP Draft Chapter <1168> Compounding for Phase I Investigational Studi ...

The USP republished a draft of a new General Chapter <1168> for public comment. Read more about the draft of <1168> Compounding for Phase I Investigational Studies.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK