1. FDA’s Perspective Continued - Where We Are ?

2. GMP Task Groups

3. Part 11 Goal - Change approach to 21 CFR Part 11 - incorporating principles of the cGMPs for the 21st Century Guidance to industry Amend 21 CFR Part 11 Rule and Preamble Narrow interpretation of scope - not cover systems incidental to creating paper records

4. Manufacturing Science Goal - ensure high efficiency and quality of pharmaceutical manufacturing and associated regulatory processes and enhance FDA’s expertise in engineering and technologies Workshop - April 2003 - information gathering ACPS

5. Changes without Prior Approval Goal - identify opportunities to allow post approval manufacturing changes without FDA review and approval prior to implementation Comparability Protocol Guidance

6. 483 Communications Goal - determine proper mechanism for communicating deficiencies/inspectional observations to industry Additional language on 483s Education and training

7. Warning Letter Goal - more scientific review of warning letters before issued and ensuring consistent application of policies and procedures New internal process being implemented

8. Dispute Resolution Goal - develop consistent policies and procedures for formally resolving scientific and technical GMP issues and improve transparency of such procedures Development of guidance 12 month pilot

9. Risk Management Goal - ensure that systematic risk management approaches are applied to allocating resources, selecting sites for inspection and determining the scope of GMP programs for human and veterinary drugs Discuss at next meeting of Manufacturing Subcommittee

10. Pharmaceutical Inspectorate Goal - Establish a staff of highly trained inspectors who will spent majority of time doing drug inspections on high risk firms and have close working relationship with Centers Working on expert PD and agreement between Centers and Field

11. Product Specialist Goal - effective and efficient use of “product specialists” on inspection teams to strengthen consistency and ensure submission reviews and inspections are coordinated and synergistic Concept paper

12. Team Biologics  Already implementing improvements to the Team Biologics program including:  Adopting an internal quality management system  Developing metrics to determine the impact of Team Biologics on the industry  Standardizing training and qualifications of the Core Team members  Implementing risk-based work planning  Increasing communications between headquarters and the field

13. Quality Systems External and internal Still determining how best to apply internal Broader implementation beyond scope of GMP initiative Implementation of quality systems approach in how conduct CMC reviews

14. International Goal - internationally harmonized approaches to assure drug product quality and encourage technological innovation ICH Other venues

15. Contracts Management Goal - expedite external studies of key issues to be addressed by GMP initiative Several contracts being researched –Effective quality systems practices - briefings –Benchmarking

16. Other Evaluation Training

17. Next Steps Role of Manufacturing Subcommittee Obviously, numerous activities which subcommittee can support Begin to prioritize Help in recognition of other areas to consider