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

Apr 11

EMA: Revised Summary of the relevant Guidelines for SmPC ...

The EMA has published a revised version of its list of relevant guidelines with regard to the contents of an SmPC. Read more about the document entitled "Scientific guidelines with SmPC recommendations".

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Apr 11

Suspension of medicines due to unreliable studies from two research labs in Indi ...

The EMA recommends the suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. Medicines where suitable alternative data are available can remain on market. Read more about the press release regarding medicines recommended for suspension.

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Apr 11

GCP - Implementing Regulation on Inspection Procedures ...

The Implementing Regulation (EU) 2017/556 has been published in the Official Journal of the European Union on 25 March 2017. Read more about the details set regarding good clinical practice inspections of clinical trials.

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Apr 05

The MRA with FDA - any Consequences for the QP? ...

On 2nd March 2017, the US FDA and the European Medicines Agency (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Learn more about the FDA-EU MRA and the consequences for the Qualified Person (QP).

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Apr 05

EMA's new Guideline on the Implementation of the ICH Q3D Guideline in the EU ...

Recently published, the EMA Guideline on the implementation of the requirements of the ICH Q3D Guideline provides support for API and medicinal product manufacturers. Learn more about what you have to consider with regard to the justification and documentation of elemental impurities in the dossier for a marketing authorisation.

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Apr 05

EMA revises Guide on Pharmaceutical Water ...

According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use".

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