Implementation of Quality Management System (QMS) for Chemistry, Manufacturing, and Controls (CMC) ReviewThe implementation of a robust quality management system will improve the quality and consistency of CMC review and enhance the efficiency of OBP's review process.</b>This key project has been retired as CDER has created new measures and key new projects for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. </b>
ON TRACKON TRACK1. Review CDER Manual of Policies and Procedures (MAPPs) and office procedures relevant to OBP4/30/2010Completed4/30/20102. Document office regulatory process5/31/2010Completed5/25/20103. Perform gap analysis of procedures relative to QMS7/31/2010Completed7/30/20104. Identify office procedures and MAPPs for future development9/30/2010Completed9/30/20105. Develop and implement new MAPPs and office procedures (1)3/31/2011 <i>(3/31/2012)</i>On Track6. Train employees on new MAPPs and office procedures (1)6/30/2011 <i>(6/30/2012)</i>On Track7. Evaluate new MAPPs and office procedures4/30/2012On Track(1) These milestones are a continuous effort and the updated milestones reflect this evergreen process.