IPEC e-newsletter - Excipients Insight June 2014 - 30-06-14


Inside this issue


EU court case clarifies EC powers on GMP deviations

A lawsuit that was heard in the EU Court of Justice in April has clarified the measures that can be taken by the European Commission when critical deviations from Good Manufacturing Practices (GMP) are found during inspections.

The ECJ judgment ruled that the EC can suspend the manufacture for the EU market of medicinal products in question and order the recall of affected batches of product - without having to prove that there is a risk to public health.

Moreover, the judgment establishes that it is the EC, not the European Medicines Agency (EMA), which has to decide the enforcement measures that must be taken in cases of critical GMP deviations based on the opinion of the EMA.

The judgment was delivered in a case involving a German drugmaker whose facility in India - manufacturing antiplatelet drug clopidogrel - failed a GMP inspection carried out by the German regulatory authorities.

Deficiencies included re-writing of manufacturing standards, quality system failures and inadequate hygiene standards.




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