A. Quality by Design (QbD) Road Map - Develop an understanding of the current state (1)The Office of Generic Drugs engaged the services of an outside contractor to assist with assessment of the current state in the Office with full documentation of findings and suggestions for review management and mechanisms for segmentation. The external group made several suggestions for improvement of the review process with projections on the impact those improvements would have. The recommendations were finalized, presented to OGD and to key managers in the Center. Work is underway to generally adopt those recommendations.
Completed1. Document the current state of QbD within the Office9/15/2010Completed9/15/20102. Document Office QbD metrics9/15/2010Completed9/15/2010(1) Impacts the CDER Office of Biotechnology Products (OBP) and the CDER Office of New Drug Quality Assessment (ONDQA)
B. Quality by Design (QbD) Road Map - Develop a comprehensive 2-3 year implementation roadmap (1)The Office of Generic Drugs engaged the services of an outside contractor to assist with assessment of the current state in the Office with full documentation of findings and suggestions for review management and mechanisms for segmentation. The external group made several suggestions for improvement of the review process with projections on the impact those improvements would have. The recommendations were finalized, presented to OGD and to key managers in the Center. Work is underway to generally adopt those recommendations.
Completed1. Document the overall QbD implementation roadmap10/1/2010Completed10/1/20102. Determine resources needed for implementation10/1/2010Completed10/1/20103. Draft a plan for internal communication10/1/2010Completed10/1/2010(1) Impacts the CDER Office of Biotechnology Products (OBP) and the CDER Office of New Drug Quality Assessment (ONDQA)
C. Quality by Design (QbD) Road Map - Implement QbD Road Map Steps (1)
CompletedNot Yet Started1. Report on early results of efforts versus implementation plan6/1/2011Completed6/1/20112. Deliver communications materials6/1/2011Completed6/1/2011(1) Impacts the CDER Office of Biotechnology Products (OBP) and the CDER Office of New Drug Quality Assessment (ONDQA)