API Starting Material Working Group Manuscripts Published

May 5, 2014

The IQ Active Pharmaceutical Ingredient (API) Starting Material (SM) Working Group has published two articles in Organic Process Research and Development.

The first of these articles, “Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material,” reviews the development of API starting material regulations over time, and discusses the industry perspective on these regulations.

The second article, “Part 2: Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium” presents the detailed results of a recent survey conducted by the IQ Working Group to assess API SM designation and justification strategies.

A third article outlining opportunities to improve the process for selecting starting materials will be published in 2015 in a special feature issue of Org. Process Res. & Dev. Devoted to a discussion of ICH Q11 issues.