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U.S. Department of Health and Human Services

About FDA

Over-the-Counter (OTC) Good Manufacturing Practices (GMP) Pilot

Description: Work with the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) to develop a pilot to identify firms manufacturing and shipping over-the-counter and/or active pharmaceutical ingredients (OTC/API) drugs to the U.S., obtain reliable information about their products, processes and inspect them as needed to determine if they are operating in compliance with cGMPs. Using a focused approach on those OTC manufacturing firms never visited by FDA investigators, the India Office will conduct telephonic Official Establishment Inventory (OEI) clean-up calls to provide HQ (CDER & ORA) with information, enabling up-to-date registration and drug listing information to increase the Agency’s understanding about the manufacturing processes and capacities of these firms within India. The results of these OEI questionnaires will be entered into FDA databases and help target limited FDA inspectional resources towards the most at-risk facilities and help to increase FDA's understanding of India’s OTC manufacturing compliance. These results will enable HQ to have a broader understanding of the risk posed by OTC drug manufacturers in India that export these products to the U.S.

OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Develop proposal

9/1/2010

Completed 9/1/2010

B. Discuss proposal with CDER & ORA to obtain consensus agreement

9/15/2010

Completed 9/15/2010

C. Develop a screening protocol and reporting mechanism

2/1/2011

Completed 10/1/2010

D. Define investigation plan and schedule for FY11/FY12

3/1/2011

Completed 10/13/2010

E. Initiate telephone questionnaires according to plan

3/31/2011

Completed 3/15/2011

F. Jointly review collected data to ascertain firms to be inspected

6/15/2011

(10/28/2011

Completed 10/28/2011

G. Begin inspecting firms

6/15/2011

(10/28/2011

Completed 10/28/2011

H. Review with CDER Compliance data collected after 15 firms called

6/30/2011

Completed 7/14/2011

I. Review data collected to ascertain process to update Center’s OEI database

6/30/2011

Completed 8/10/2011

J. Complete 30 OEI questionnaires

9/30/2011

Completed 9/30/2011

K. Complete surveillance inspections of OTC firms based on the agency’s risk model in questionnaires completed

9/30/2011

Completed 9/30/2011

L. Complete 100 OEI questionnaires (1)

N/A

N/A N/A

Footnotes

  • (1) Milestone was not completed while this project was tracked in FDA-TRACK.

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.