FDA Releases Guidance on Cooperative Manufacturing for Biologics

December 11, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

Rockville, MD (Dec. 4)-The US Food and Drug Administration released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the August 1999 draft. The guidance provides information regarding various cooperative manufacturing arrangements used to produce biological products and the agency's current thinking about licensing strategies for planning flexible manufacturing arrangements.

The guidance was developed in response to the growing number of companies that are choosing to perform only limited aspects of the manufacturing process while sharing or contracting other aspects in accordance with specific manufacturing arrangements. As stated in the guidance, “Since cooperative manufacturing arrangements can take a considerable amount of time to develop, this guidance may also be useful for planning purposes in the early phases of product development.”

The document discusses short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements. For these arrangements, the regulatory requirements and recommendations, as well as the manufacturer’s responsibility, are described.
The guidance can be viewed here and the Federal Register announcement can be viewed here.