Comment Period Open on Draft Guidance on Cooperative Manufacturing for Biologics

Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics. The announcement, released in the Federal Register 72 (40) Docket 1999D-2013, relates to “cooperative manufacturing arrangements applicable to biological products licensure under section 351 of the US Public Health Service Act,” including short-supply, divided manufacturing, shared manufacturing, and contract manufacturing arrangements.

Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements for the licensed manufacturer, the contract manufacturer, and the final-product manufacturer. Specifically, the draft guidance details the following:

• Notification of any proposed change in the product, production process, quality controls or facilities

• Notification of results of tests and investigations related to or impacting the product

• Notification of products manufactured in a contract facility

• Standard operating procedures.

The comment period for the draft guidance ends September 21, 2007.