Dale Carter

Dale Carter is manager of product quality and management systems, Office of Compliance and Ethics, at Archer Daniels Midland Company (Decatur, IL).

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.

This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.