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

Mar 07

Sterile plastic containers for human blood and blood components ...

A draft for Ph. Eur general chapter 3.2.3. Sterile plastic containers for human blood and blood components has recently been published for comments in Pharmeuropa. It is proposed to delete the abnormal toxicity test (2.6.9) (ATT) from the Tests section.

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Mar 02

New GDP Rules in Russia - what you need to know ...

From 1 March 2017 there are new GDP rules valid in Russia . All pharmaceutical companies distributing to Russia should be aware of the new Russian GDP regulations.

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Mar 02

The GMP/GDP Interface: When the Inspector comes ...

Storage facilities are not only a hot topic in GDP inspections. GMP inspectors also make observations in these areas, as some examples show, which were published by the U.K. authority MHRA.

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Mar 02

What are the regulatory Definitions for "Ambient", "Room Temperature" and "Cold ...

What do storage requirements like, for example "ambient", "room temperature" and "cold chain" exactly mean? Worldwide, there are different definitions for these storage requirements.

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Mar 01

Delegated Regulation on the Anti-Counterfeiting Directive - New EU Requirements ...

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission has released version 5 of its Questions and Answers on safety features and the German initiative securPharm has just published the Status Report for 2017. Read more about the SecurPharm Status Report 2017 and about the EU's Q&A document on safety features.

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Mar 01

GMP Requirements for Certificates of Analysis (CoA) ...

Certificates of Analysis (CoA) have to be issued for excipients, APIs, packaging materials and finished products. Regarding those certificates, there are a number of guidelines. A closer look at these guidelines shows that there are several regulatory requirements which are often unknown. Read more about GMP/FDA compliant Certificates of Analysis (CoA).

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