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Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.
The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more about the EMA's implementation plan for safety features.
It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design.
Dr Tobias Posset, Head of Production Support at Roche Diagnostics in Mannheim, Germany and chairman of the ECA Visual Inspection Group, was recently appointed into expert group 12 of the EDQM (European Directorate for the Quality of Medicines & Health Care). Amongst other things, this expert group develops recommendations for the revision of monographs concerning visual inspection. Learn more about Dr Posset's appointment to the EDQM Expert Group.