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

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.