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

PQR: a common Misunderstanding when it comes to Starting Materials ...

It seems that there are some misinterpretations with Chapter 1.10 of the EU-GMP Guidelines, according to a blog entry of the British MHRA.

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Apr 11

Use of Hoses in the Pharmaceutical Industry ...

Hoses are more often used than one thinks. On the one hand they are used in routine operations, on the other hand they can also be utilised as interim solution before a new pipe is drawn. They then fall into the first case situation. While one pays more consideration to pipes, their material quality and surfaces, hoses are often neglected. But what about requirements for hoses? Are there any?

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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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