2005D-0312 Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
FDA Comment Number : EC2
Submitter : Ms. Jenny Peters Date & Time: 12/09/2005 10:12:37
Organization : Amgen
Category : Drug Industry
Issue Areas/Comments
Line 35 - Addition of the following statement: Impurities arising from excipients present in the drug product or extracted or leached
from the container closure system are not covered by this guidance document.