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News about GMP/cGMP

EMEA publish Q&A on Calculation of Thresholds for Impurities

Question: What is the basis for the calculation of thresholds to set limits for impurities in the finished product specification?

 

Answer:

The calculated thresholds should be based on the highest maximum daily dose of the respective active substance in authorised medicinal products. The threshold for impurities should be the same for all strengths.

The same rule applies for combination drugs; the highest possible combined strength should be used for setting the thresholds.

The maximum daily dose used for threshold calculation should be the same for a given active substance irrespective of the medicinal product.

Source: EMEA - Inspections - Quality Working Party - Questions & Answers, July 30, 2009

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