FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
Title:
FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf
Content:
It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.