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U.S. Department of Health and Human Services

About FDA

Implementation of Quality Management System (QMS) for Chemistry, Manufacturing, and Controls (CMC) Review

Description: The 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.

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.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Review CDER Manual of Policies and Procedures (MAPPs) and office procedures relevant to OBP


Completed 4/30/2010

2. Document office regulatory process


Completed 5/25/2010

3. Perform gap analysis of procedures relative to QMS


Completed 7/30/2010

4. Identify office procedures and MAPPs for future development


Completed 9/30/2010

5. Develop and implement new MAPPs and office procedures (1)

3/31/2011 (3/31/2012)

On Track

6. Train employees on new MAPPs and office procedures (1)

6/30/2011 (6/30/2012)

On Track

7. Evaluate new MAPPs and office procedures


On Track


  • (1) These milestones are a continuous effort and the updated milestones reflect this evergreen process.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.