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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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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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

Oct 18

Rationale to the revision of USP Chapter <381> Elastomeric Closures for In ...

The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.

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Oct 18

Important Questions and Answers concerning the Audit Trail Review - Part 2 ...

The webinar "Audit Trail Review" took place in February 2017 - with the goal to address the main elements of data integrity and audit trail reviews. During this webinar more than 50 questions were asked. As time did not allow to answer all of them, the webinar's speaker, Dr Wolfgang Schumacher, provided comprehensive answers later. Find out what questions regarding Audit Trail Review were asked and how they were answered.

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Oct 18

Warning Letter due to Deficiencies in Filling System Design/Testing Particulate ...

Due to deficiencies in the design of the filling system as well as the testing for particulate matter, the FDA has issued a warning letter to an Italian manufacturer of sterile products in Rome. Read more about the deficiencies resulting in a Warning Letter. 

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Oct 17

Responses to public consultations on recommendations related to clinical trials ...

The feedback to the public consultations on recommendations related to clinical trials is now available online. Read more about the comments to the four draft guidelines issued in June 2016 regarding clinical trials.

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Oct 17

New EU GMP Guideline for IMPs ...

The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.

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Oct 17

Similarity by Design: EMA Reflection Paper on statistical Methodology for compar ...

The European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.

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