FDA Offers Guidance for Reporting Deviations in Biologics Manufacturing

Rockville, MD (Oct. 19)-The US Food and Drug Administration (www.fda.gov) issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices (CGMP) for biological products.

The guidance,Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components finalizes the draft guidance of the same title dated August 2001. Notice of the guidance was published in the Fed. Regist. 71 (202), 61781–61782, Oct. 19, 2006.

The guidance document is intended to provide assistance to licensed manufacturers of biological products in the reporting of any event associated with manufacturing, including testing, processing, packaging, labeling, or storage, or with the holding or distribution of a licensed biological product that may affect the safety, purity, or potency of the product.

The guidance document offers assistance in determining when a report is required, who submits the report, what information to submit in the report, the time frame for reporting, and how to submit the report.