FDAsRoleinPlantDesignReviews.pptVIP

Pre-op Review RequestOutside the U.S. U.S. Food and Drug Administration Office of Compliance Drug Manufacturing and Product Quality Bldg. 51 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: Pre-op Review Request FDA’s Role in Plant Design Reviews Erin D. McCaffery, Investigator New Jersey District Office erin.mccaffery@ May 19, 2009 Overview cGMP Requirements cGMP and Pre-approval Coverage of Plant Design FMD 135 Consultants FDA Resources Current Compliance Issues cGMP Requirementsfor Facility Design 21 CFR 211 subpart C--Buildings and Facilities 211.42 Design and construction f