Part 2: Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium

Abstract

Designation and justification of active pharmaceutical ingredient starting material (API SM) is a standard part of the drug development and commercialization process. However, knowledge of current practices used within the industry varies, depending on the individual company interpretation of regulatory guidelines. In 2011, the API and Analytical Leadership Groups within the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium or IQ), established a Working Group on API SMs to determine current practices within the pharmaceutical industry on this topic. A survey composed of four key areas, representing (1) drug substance (DS) attributes, (2) API SM attributes, (3) control strategy, and (4) regulatory practices and strategy, was developed and distributed to IQ member companies. Data representing a total of 50 API SMs (used to prepare 24 late stage clinical or marketed DSs) were obtained. This data was used to gain a better understanding of approaches utilized by pharmaceutical companies to define API SMs. The data gathered was anonymous, and the key information obtained is summarized in this manuscript. While no single approach to justifying API SMs emerged from the survey data, key trends were evident that will provide valuable insight for the reader on this important topic.