FDA Guidance for Industry: ANDAs: Impurities in Drug Products
Title:
FDA Guidance for Industry: ANDAs: Impurities in Drug Products
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072861.pdf
Document Type:
Guidance for Industry
Content:
This guidance provides recommendations on what chemistry, manufacturing and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of degradation products in drug products.