Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective

Designation and justification of an Active Pharmaceutical Ingredient Starting Material (API SM) is an important aspect of the drug development and commercialization process and defines the point at which the GMP manufacturing process starts (ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients). In 2014, the API SM Working Group of the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium or IQ), composed of representatives from the Active Pharmaceutical Ingredient and Analytical Leadership Groups, published two manuscripts on API SMs that provided (1) a review and industry perspective of the regulatory guidances that support designation and justification of API SMs, and (2) a summary of current practices across member companies of the IQ Consortium on designation and justification of API SMs based upon a survey completed by the IQ member companies. The information and data presented in these manuscripts provided a thorough overview of current practices but more importantly revealed the absence of a universal approach within the pharmaceutical industry to justifying API SMs. Using the information from manuscript 1 and 2, this manuscript, which represents part 3 of the topic series, will provide a guiding framework that is based upon the principles described in ICH Q11 and which includes relevant experiences of the IQ member companies, for the justification of a proposed API SM to the regulatory agencies.