WHO TRS (Technical Report Series) 961, 2011 Annex 1

Release procedure of International Chemical Reference Substances

International Chemical Reference Substances (ICRS) were in the past first provisionally adopted by the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations and then finally adopted by the Expert Committee on Specifications for Pharmaceutical Preparations during its annual meeting.

Since April 2010 the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been responsible for the establishment, preparation, storage and distribution of WHO ICRS. For the analytical characterization of ICRS, EDQM follows the General guidelines for the establishment, maintenance and distribution of chemical reference substances.

EDQM will issue an individual analytical report after:

— the establishment of a new reference substance;

— analysis of candidate material for stock replenishment; and

— monitoring the stability of material in stock.

The Expert Committee members newly adopted the following procedure:

Analytical case-reports to be reviewed a priori by the Secretariat with assistance from the collaborating laboratories. If the testing has been performed according to the above-mentioned adopted guidelines (1) and the candidate material has been proven to be suitable, the Secretariat with assistance from the collaborating laboratories, will then in future provisionally release the ICRS. The distribution of the ICRS will start after the provisional release.

The analytical case-reports together with a consolidated EDQM annual report describing all activities related to the establishment of ICRS will then be distributed to the WHO Expert Committee on Specifications for Pharmaceutical Preparations for adoption. The analytical case-reports will be appended to the annual report as annexes.

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WHO TRS (Technical Report Series) 961, 2011 Annex 1: pdf

WHO TRS (Technical Report Series) 961, 2011 Annex 1: