Issue Date: January 25, 2011
Issued by: Center for Veterinary Medicine
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Process Validation: General Principles and Practices: Guidance for Industry
This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
Download the Guidance Document
