Release procedure of ICRS

Overview

During its forty-fifth meeting in 2010 the Expert Committee on Specifications for Pharmaceutical Preparations agreed on a release procedure for International Chemical Reference Substances (ICRS). Based on this procedure case-reports issued by the custodian centre for ICRS after analytical testing of candidate material were reviewed by the Secretariat with assistance from collaborating laboratories. If the testing was performed according to the General guidelines for the establishment, maintenance and distribution of chemical reference substances (2) and the candidate material was found suitable, the Secretariat, in cooperation with the collaborating laboratories, released the ICRS provisionally. In accordance with the rules, the case-reports were subsequently submitted to the Expert Committee on Specifications for Pharmaceutical Preparations during its subsequent meeting, for final adoption. After provisional release the custodian centre for ICRS started the distribution of the ICRS.