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EMA Taking Steps To Mitigate ‘Critical’ Product Shortages Due To GMP Problems

 
• By Ian Schofield

The EMA is consulting on changes to the template for declaring non-compliance with good manufacturing practice, as the first step in a revision of the procedures for handling GMP-related shortages of “critical” medicines.

Compliance
The EMA is updating its procedures to help avoid drug shortages in cases of GMP non-compliance

The European Medicines Agency is planning further measures to improve and harmonize the procedures for dealing with instances of serious non-compliance with good manufacturing practice (GMP) that could lead to shortages of “critical” medicines. They include specifying the circumstances under which batches of affected products could be released.

The EMA says that compliance with GMP is “an essential part of the pharmaceutical quality system,” and that non-compliance can...

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