GMP: Recommendations of the EMA for the risk assessment of metallic impurities in approved drugs

Recently, with the inclusion of the Guideline ICH Q3D in the collection of \"Scientific Guidelines\", the EMA established the deadlines for its entry into force (see our news \"The CHMP adopts the Guideline ICH Q3D as a \'Scientific Guideline\'\" of 21 January 2015). For drug producers, there is a relatively short transition period of 20 months to implement the requirements of the ICH Q3D; as of December 2017, the provisions for approved medicines will be mandatory.