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One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”.
One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening and updating guidelines on the testing of products.