Comparability Protocols for Human Drugs and Biologics: Guidance for Industry

How do you handle post-approval changes to your products?  New draft FDA guidance document establishes a framework to ensure you effectively use your product and process knowledge and understanding to prepare a Comparability Protocol that employs the tools in ICH Q8 to Q11.  It also provides guidance on a robust control strategy, incorporates risk management over the product’s life cycle and describes elements of an effective pharmaceutical quality system.

Learn more and download the guidance here.