EMA proposes new system for assessing chemically active residue

Published: 25-Jan-2013
Regulatory

Would be more sophisticated than current blanket limit of 10ppm


A new system for assessing the amount of chemically active residue from one medicine that may contaminate another has been proposed by the European Medicines Agency (EMA).

The system would be more sophisticated than the current blanket limit of a maximum permitted contamination of 10ppm of an active substance made previously by the same manufacturing equipment.

The idea is that a maximum contamination level would be set for each active ingredient at the highest dosage where it will have no effect.

‘The current limits do not take account of the available pharmacological and toxicological data and may be too restrictive or not restrictive enough,’ EMA said.

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