Quality-by-Design Pilot Program

(FDA: Rockville, Maryland) -- The Food and Drug Administration is seeking volunteers from pharmaceutical companies to participate in a pilot quality-by-design (QbD) program.

The purpose of the program is to gain more information in the areas of chemistry, manufacturing, and controls, and to facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology and pharmaceutical products through the use of expanded change protocols. This program will focus on products reviewed by FDA's office of biotechnology products, in the office of pharmaceutical science from the Center for Drug Evaluation and Research.

Under quality by design, manufacturing will depend on a risk-based approach linking attributes and processes to product performance, safety, and efficacy. The agency's intention to establish a QbD approach to pharmaceutical quality is based on its 2004 report entitled, “Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach.”

The pilot is open to original submissions of and supplements to biologic license applications or new drug applications reviewed by OBP. Applicants must file by Sept. 30, 2008.

For more details and to view submission process, visit www.fda.gov/OHRMS/DOCKETS/98fr/E8-14999.htm.

To view the 2004 “Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach” report, visit www.fda.gov/Cder/gmp/gmp2004/GMP_finalreport2004.htm

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