EMA Clarifies Requirements for Impurities, Stability

April 26, 2010
Drugmakers can use a new European Medicines Agency (EMA) question-and-answer document to help prepare for EU inspections, specifically with regards to drug impurity levels and stability. Limits for impurities in investigational drugs should mirror impurity profiles of batches of the active substances that are used in nonclinical and clinical trials of the drugs, the EMA says. Manufacturers are not required to comply with International Conference on Harmonisation guidelines as long as the results are properly justified.
International Pharmaceutical Regulatory Monitor