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|Articles|July 27, 2007
Comment Period Open on Draft Guidance on Cooperative Manufacturing for Biologics
Author(s)Pharmaceutical Technology Editors
The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
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Rockville, MD (July 23)-The
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 Specifically, the draft guidance details the following: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The comment period for the draft guidance ends September 21, 2007.
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