FDA - Guidance for Industry - Process Validation: General Principles and Practices

Author: Krissy Dempsey - Marketing Manager

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. 

To read the full document go to https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf 


You may also be interested in:
Get In Touch With Our Experts

Do you want to Start a Project, Request a Quote or have General Inquiries? Contact us today.

Interested in learning more about our products, capabilities, and solutions?  Schedule a Lunch & Learn today.