International Conference on Harmonization Guidelines
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory and industry authorities of Europe, Japan and the United States. The purpose of ICH is to harmonize the interpretation and application of technical guidelines. Harmonization and Multilateral Relations representatives act as liaison for the ICH Steering Committee, experts, as well as the ICH Secretariat. In 2006, a majority of the ICH guidance was finalized.
OGD follows ICH guidance for impurities in drug substance as well as drug products. The guidance used most commonly by OGD is:
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