Comparability Protocols for Human Drugs and Biologics

The U.S. Food and Drug Administration has produced draft guidance for industry of interest. It is titled “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.”

The introduction reads:

This guidance provides recommendations to holders of applications for human drugs and biologics on implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use of a comparability protocol (CP). It replaces the draft guidance that published in February 2003, titled Comparability Protocols: Chemistry, Manufacturing, and Controls Information.

A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality). Submission of a CP in an original application or prior approval supplement (PAS) allows the agency to review a description of one or more proposed CMC postapproval changes, supporting information including any analysis and risk assessment activities, a plan to implement the change(s), and, if appropriate, a proposed reduced reporting category for the change(s). Approval of the original application containing the CP or a subsequent PAS containing the CP can provide an applicant with an agreed-upon plan to implement the specified change(s), and in many cases, a justification to report the change(s) in a reduced reporting category, contingent upon the applicant’s analysis of the data from the implementation of the change…”

The document can be accessed here: FDA

Posted by Dr. Tim Sandle