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 26

New Analysis of GMP Inspections by MHRA ...

The British MHRA has published the 2016 GMP inspection deficiency data trend. The report lists interesting examples for all relevant chapters and annexes of the EU-GMP Guidelines.

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Apr 26

USP Q&A Paper on Pharmaceutical Water ...

The website of the US Pharmacopoeia (USP) comprises a document with frequently asked questions and answers on the subject of pharmaceutical water. The not very well known page contains some very interesting points.

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Apr 26

FDA Warning Letter due to incorrect Certificates of Analysis ...

At the beginning of March 2017, Lumis, an API manufacturer in China, received a Warning Letter from the the US FDA. During the FDA inspection the certificates of analysis (COAs) were criticized. The issued certificates did not contain all relevant information on the quality that would have been necessary for the customer. Learn more about the FDA Warning Letter issued to Lumis.

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Apr 19

Impurities: Top 10 Deficiencies in New Applications for Certificates of Suitabil ...

The EDQM has recently published a list of the top 10 deficiencies found in CEP applications.Find out how to avoid undesired inquiries from the EDQM on impurities in starting materials, elemental impurities and residual solvents in the framework of an application procedure.

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Apr 19

European QP Association Survey on the Certification of Batches with GMP Issues ...

To ascertain the information required by QPs to allow release of medicinal products impacted by a statement of non-compliance, the European QP Association (EQPA) performed a survey among its members. This survey on the certification of batches with GMP issues generated some interesting results.

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Apr 19

Packaging: Pharmeuropa Draft Chapters regarding PVC ...

In Pharmeuropa 29.2 several drafts of general chapters regarding packaging components and materials made of PVC have been published for comment. Read more about the drafts on materials and containers based on plasticised poly(vinyl chloride).

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