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

Jun 14

FDA Warning Letter due to Incorrect Sampling ...

Incorrect sampling has led to an FDA Warning Letter for an API manufacturer in China. The FDA inspectors criticised that around 10% of the API batches manufactured exceeded the impurity limit set. Read more about this FDA Warning Letter.

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Jun 07

FDA Warning Letter shows the Importance of Sampling Plans and Strategies ...

A recent FDA Warning Letter cited a lack of scientifically sound and appropriate sampling plans for inspection. It stated that the company had no scientific justification for the number of reserve samples selected for the yearly visual examination aimed at identifying any evidence of drug product deterioration. Similarly, the company lacked appropriate statistical sampling plans for the inspection of paper label rolls.

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Jun 07

Production of APIs without any Minimal GMP Standards leads to a Warning Letter f ...

Even 17 years after the publication of the ICH Q7 Guideline, some companies still manufacture without complying with the most important binding GMP instructions and recordings. Read more about what minimal GMP requirements FDA inspectors expected but couldn't find at Changzhou Jintan Qianyao.

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Jun 07

Visual Control by Doctor and Patient? ...

To avoid a supply shortage, batches of a lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer.

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May 31

Warning Letter due to non-transparent Supply Chain of APIs ...

The Indian company Sal Pharma has received a Warning Letter due to serious deficiencies with regard to the procurement and storage of APIs, their distribution and disguising information. Read more about what makes the non-transparency of the API supply chain and the procedures highly suspect for the FDA inspectors.

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May 31

More Non-Compliance Statements issued by EMA ...

EU/EEA inspectors performed almost 2.300 GMP inspections last year. In these inspections they found an increasing number of Non-Compliance Statements.

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