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

Dec 18

Gene Therapeutics - FDA updates Requirements for CMC Information ...

In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.

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Dec 18

Transfusion Transfer of Babesiosis - FDA Draft: Recommendations for Risk Minimiz ...

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.

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Dec 18

FDA Draft Guidance on the risk of Bacterial Contamination of Blood Platelets ...

With a new draft guidance on the risk of bacterial contamination of blood platelets for transfusion purposes, the FDA wants to give updated recommendations on risk minimization to affected donor institutions and transfusion centers.

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Dec 12

British Regulatory Authority MHRA criticises Cross Contamination Issue ...

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.

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Dec 12

Safety Features: EU Commission issues Version 12 of Q&As ...

The European Commission has reviewed their list of questions and answers regarding safety features and issued it as version 12. Find out what changed in the Q&As on safety features.

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Dec 12

Warning Letter for Korean Manufacturer due to Poor Sterile Practices ...

As a result of repeated deviations in the area of aseptic manufacturing, a Korean manufacturer has received a Warning Letter from the FDA.

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