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

Feb 01

USP´s Intent to Revise and to Develop Elastomeric Packaging Chapters ...

The U.S. Pharmacopeial Convention (USP) proposes to revise its elastomeric packaging chapters. Find out more about these revisions of USP chapters <381>, <382>, <1381> and <1382>.

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Feb 01

New and Revised Draft GMP Guidances FDA is planning to publish 2017 ...

FDA's CDER has published a Guidance Agenda with planned new and revised Draft Guidances for 2017. Some of the planned FDA Guidances could be interesting for the GMP area.

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Feb 01

PIC/S and European Medicines Agencies agree on Audit Cooperation ...

Most recently, PIC/S has published on their website a "Letter of Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme". Read more on the objective of the PIC/S and EMA agreement.

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Jan 25

How important is "Data Governance" for your Company? ...

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.

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Jan 25

USP´s Intent to Revise Chapters on Biocompatibility of Packaging Systems and Me ...

The U.S. Pharmacopeial Convention (USP) proposes the revision of general chapters regarding the biocompatibility of materials used in pharmaceutical packaging systems, medical devices and implants. Read more about the suggested modernization of general chapters <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.

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Jan 25

Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Par ...

As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.

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