This document aims to assist in the establishment of a single set of global specifications for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them. It applies to new drug substances and new drug products which have not been registered previously in the ICH regions.

Keywords: Specification, active substance, finished product, chemical, control, test, acceptance criteria, limit, release

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