European Conference on APIs

Europe's leading event on active pharmaceutical ingredients takes place on 24-26 October, 2018 in Budapest, Hungary.

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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 16

New defect Evaluation List for Moulded Glass out now ...

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Moulded Glass which includes an appendix with example pictures of specific defect characteristics is out now.

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Oct 16

Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing ...

FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".

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Oct 16

Revision: FDA Guideline on Adaptive Designs for Clinical Trials ...

In September, the US Food and Drug Administartion published a draft guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics. It is the revision of the existing guidance from 2010.

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Oct 16

FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and ...

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.

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Oct 16

EMA: Work on Annex 1 and Annex 21 will continue ...

Because of Brexit, the European Medicines Agency (EMA) further needs to reduce activities. However some EMA acitivities will continue as planned.

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Oct 16

Missing Investigation of OOS Results leads to FDA Warning Letter ...

The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.

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