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

Jul 26

EMA non-compliance report on Indian manufacturer of sterile medicinal products ...

During a pre-approval inspection, the French supervisory agency found major deviations by an Indian manufacturer of sterile medicinal products. Find out more details about the EMA's non-compliance report here.

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Jul 26

API starting materials: EMA publishes updated reflection paper ...

In the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised. Read more on how to deal with intermediates along the synthesis route which are already monographed in the Ph. Eur. or part of an already authorised product.

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Jul 26

The API warning letters of the last 21 months - facts and trends ...

The warning letters issued to API manufacturers, viewed over a period of one and three quarter years, repeatedly point to fundamental deficiencies. Read here which GMP violations concerning quality assurance, quality control and data integrity were criticised by the FDA inspectors.

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Jul 26

The MRA between Japan and EU will be extended ...

The Mutual Recognition Agreement on GMP products (MRA) between the EU and Japan will soon be amended to include APIs, biologics, and vaccines.

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Jul 19

Heparin in the FDA's Focus once more: Warning Letter for Chinese Contract Lab ...

Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.

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Jul 19

EMA's updated Implementation Plan for the Introduction of Safety Features ...

The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more about the EMA's implementation plan for safety features.

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