Part VII: GMPs fdfc Small-Molecule Drugs in Early DevelopmentWorkshop Summary

• Published in: Pharmaceutical Technology Vol. 38; no. 12; p. 38
• Main Authors: Li, Q Chan, Pellet, Jackson D, Szulc, Michael, Trone, Mark D, Wong-Moon, Kirby
• Format: Trade Publication Article
• Language: English
• Published: Monmouth Junction MultiMedia Healthcare Inc 01-12-2014
• Subjects: Biotechnology industry; Consortia; Drug dosages; Good Manufacturing Practice; Manufacturing; Patient safety; Pharmaceutical industry; Pharmaceuticals; Series & special reports; United States > US
• ISSN: 1543-2521; 2150-7376

The fourth part of the series on GMPs for small-molecule drugs is presented. A primary topic of interest during the presentations and associated breakout session discussions included justification of impurity specifications using simplified control strategies for formulations like powder in bottle or powder in capsule, and clearly communicating control strategies in the investigational new drug application. This emphasis within the submission may provide clarity when additional tests not listed on the specifications are an important part of the control strategy or provide product understanding. During the discussion, several companies outlined their approach as being conservative and consistent with ICH guidelines with a concern that any questions of the qualification of impurities could delay clinical trials. Simply providing a summary of what additional tests are being used or what attributes are being monitored for process understanding with no commitment to continue may provide clarity to regulatory reviewers.