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News about GMP/cGMP
EMEA publish Q&A on Calculation of Thresholds for Impurities
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