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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 Description | Milestone Date | Milestone Status | Milestone 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 Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
