Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Abstract

ensure product quality and process / batch consistency, supplemented by current Good Manufacturing Practices (cGMP) and thorough product understanding. The guidance was developed for the approval of commercial products and was not intended for clinical development, although the concepts are still applicable. During development, knowledge of critical quality attributes (CQAs) may be limited, as significant changes in both synthesis / process (API) and formulation / process (drug product) would be anticipated. ICH M3 provides some useful insight for qualifying impurities during the development phase: