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 20

Burkholderia cepacia - FDA Advice on Contamination Risk ...

Recent recalls determined FDA advice to drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products.

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Jun 20

Guidance for Industy: Transmission Risk of West Nile Virus from Living Donors of ...

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated  the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

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Jun 20

Revisions of EP Chapter 5.1.8, 2.6.36, 2.6.38 and Monograph 3053 ...

In April, the Pharmeuropa issue 29.2 was completed including the revision of chapter 5.1.8. "Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts Used in their Preparation".

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Jun 14

Indian Sterile Manufacturer receives a second Warning Letter ...

In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.

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Jun 14

Chinese FDA is performing more international Inspections ...

The China Food and Drug Administration has published the "Annual Report of Drug Inspection 2016" summarising CFDA's last year's inspection results.

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Jun 14

APIs from UK will need Written Confirmation ...

As indicated, a series of Questions and Answers on the Brexit will be provided by the EMA and the European Commission. Now, EMA has published a first set of these Q&As on Brexit.

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