This project has been archived.
API Starting Material Working Group
Practices used in the selection and justification of active pharmaceutical ingredient (API) starting materials (SM) for commercial New Chemical Entities (NCEs) vary across the pharmaceutical industry and may be influenced by company experience and interpretation of regulatory guidance.
The goal of the API SM Working Group is to develop a science-based strategy for selection and justification of API SMs. The Working Group is reviewing current industry practice on selection, designation, characterization, and justification of API SMs using case studies obtained from the IQ member companies. Based upon the results of this work, the Working Group will define the “control strategy” in the GMP sequence between the API SMs and Drug Substance specifications. The Working Group hopes to build consensus with regulatory authorities on this approach, and share its work through publication.