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 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.

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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.

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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.

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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.

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May 11

GCP: EMA Draft Guideline relating to the Trial Master File ...

On 12 April the European Medicines Agency (EMA) has released a draft guideline on good clinical practice (GCP) compliance in relation to Trial Master Files (TMF) for public consultation. The guideline is part of the work related to the implementation of the new Clinical Trial Regulation (EU) 536/2014. It also contains the revised version of the reflection paper on TMF, considering comments collected during public consultation. Read more about the Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.

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May 10

EMA-FDA QbD Pilot Program Report ...

In April 2017 the European Medicines Agency (EMA) published the final report of its joint pilot programme with the United States (US) Food and Drug Administration (FDA) for the parallel assessment of sections of applications relevant to quality by design (QbD). Read more about the final Report from the EMA-FDA QbD pilot program.

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