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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 ONDQA’s review processes.


This key project has been retired as CDER has created new measures and key 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. Document and catalog existing Office processes

6/30/2010

Completed 6/10/2010

2. Review existing CDER MAPPs and Office procedures

10/1/2010

Completed 11/29/2010

3. Perform Gap Analysis

10/1/2010

Completed 10/1/2010

4. Identify need for office procedures and MAPPs (1)

6/30/2011 (9/1/2011)(11/1/2011)

Completed 12/15/2011

5. Develop new MAPPs and office procedures

12/23/2011

Completed 12/23/2011

6. Train employees on new procedures

3/31/2012

Completed 12/23/2011

7. Establish Methodology to evaluate performance and capability of office procedures

9/30/2012

On Track

Footnotes

  • (1) Completion of this key project is dependent on completion of the quality manual which is currently an ongoing effort.
  • The dates in italics under the milestone due dates are revised milestone due dates which were updated.

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.

Glossary

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.