FDA Highlights Responsibilities for Finished Biologics Manufacturers

The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements. The document, “Cooperative Manufacturing Arrangements for Licensed Biologics,” issued jointly by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, places responsibility for the quality of the final drug product with the licensed manufacturers of the finished product.

The document provides guidance for short supply, divided manufacturing, and shared or contract manufacturing arrangements. In contract manufacturing agreements, the product license holder is responsible for ensuring product quality and for ensuring that the contract manufacturer complies with product and establishment standards. If the contract manufacturer fails to comply with good manufacturing practices regulations, compliance actions may be considered to be against the license manufacturer.

In divided manufacturing agreements, the licensed manufacturers share responsibility, and each must notify the appropriate FDA center of proposed changes in the manufacture, testing, or specifications of its product.

In short supply agreements, a licensed manufacturer may obtain the initial and partially manufactured version of the product from unlicensed facilities under certain limited circumstances.

The revised guidance revises the draft guidance of the same title dated August 1999 and replaces “FDA’s Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics” published in the Federal Register on November 25, 1992.