Urgent Meeting: Nitrosamin Impurities

Since EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer in June 2018, more and more cases of drug substance and drug product batches contaminated with Nitrosamines have come up. During this conference on 18 February 2020 in Frankfurt the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products will be discussed.

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Weekly GMP Newsletter

The weekly Newsletter is now available here.

Read the GMP Newsletter dated 15.01.2020

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 – 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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Latest GMP News

Jan 21

FDA´s Advice for Sponsors of Adaptive Design Clinical Trials ...

The FDA published a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics.

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Jan 21

ICH E9 Addendum adopted ...

The ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.

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Jan 16

Clinical Trials Regulation Questions & Answers Version 2.3 ...

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.

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Jan 16

From GVP to GMP: MHRA´s tips for QPs to stay compliant ...

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.

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Jan 16

Endotoxin and Pyrogen Testing - Challenges for Biotechnological and Biopharmaceu ...

The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.

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Jan 16

Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May ...

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.

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