IPEC-Americas' Updated Significant Change Guide for Bulk Pharmaceutical Excipients

The recently issued International Pharmaceutical Excipients Council of the Americas Significant Change Guide for Bulk Pharmaceutical Excipients was developed to help excipient manufacturers evaluate the significance of manufacturing changes and to assess the risk that those changes will affect drug products that contain the excipient. The guideline also explained which changes should prompt communication with drug manufacturers. Recent developments in the business climate have necessitated an update to the significant change guide. Although the significant change guideline focuses on whether a change to an excipient's manufacture warrants notification to a drug manufacturer, the guide serves a secondary purpose as well. A change in an excipient's impurity profile can alert the excipient manufacturer or its customer to the presence of a foreign substance.