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“Pharmaceutical GMP’s for the 21st Century”: FDA’s New Initiative on Drug Product Quality

“Pharmaceutical GMP’s for the 21st Century”: FDA’s New Initiative on Drug Product Quality

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“Pharmaceutical GMP’s for the 21st Century”: FDA’s New Initiative on Drug Product Quality

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Presentation Transcript

  1. “Pharmaceutical GMP’s for the 21st Century”: FDA’s New Initiative on Drug Product Quality Janet Woodcock, MD Director, Center for Drug Evaluation and Research Food and Drug Administration October 25, 2002

  2. Agenda • What is the initiative about? • Background • Major themes/principles • Immediate steps • Longer term projects • What do we hope to accomplish?

  3. Long Term Strategic Goals (GPRA):Long Term Strategic Goals (GPRA):What is this Initiative? It’s a BIG- Picture Look • Not just about cGMPs - about regulation of product quality • FDA’s system involves a standard setting component, submission review component, and an inspectional component • How effective is this system in achieving its objectives? What ARE its objectives? How do the component parts operate? Cooperate?

  4. Background • FDA’s product quality regulatory system devised MANY decades ago • Incremental adjustments since then: • Major revision of cGMP regs in 1978 • CDER-ORA agreement early 90’s • SUPAC, FDAMA changes in submission review, later 90’s • Team Biologics

  5. Background: Significant changes in pharmaceutical environment have occurred in last several decades • More approved medicines - greater role in healthcare • Advances in pharmaceutical sciences & manufacturing technologies • Advances in science & management of quality • Application of biotechnology • Globalization of industry

  6. Background: FDA’s Physical Presence has Decreased due to Resource Constraints Domestic Non-Gas Drug GMP Inspections planned

  7. Major Themes and Principles • Risk-based orientation • Put resources against highest risks • Requirements commensurate with risk • Science-based regulation • Scientific risk assessments • Recognize & facilitate scientific and technological advances

  8. Major Themes & Principles • Maintenance of strong public health protection • Will not interfere with current enforcement • Achievement of objective expected to result in improvements • International cooperation

  9. Principle: Integrated Quality Systems Orientation • Assessing Innovations in Quality Systems • “Quality revolution” • Benchmarks in quality from other sectors • Assessing Drug Quality regulation as an Integrated System

  10. Immediate Steps (Six months) • Hold series of scientific workshops with key stakeholders • Enhance scientific & technical expertise • Encourage greater use of comparability protocols • Increase use of product specialists in inspections

  11. Immediate Steps • Have Centers do technical review of all warning letters • Re-evaluate 483/disclosure issue • Shift lead on Part 11 to CDER • Develop a technical dispute resolution process

  12. Immediate Steps • Alterations to work planning process - move to risk-based approach • Evaluation of Team Biologics

  13. Overall Approaches • External review (under contract) • Process evaluation • Science evaluation (probable) • Potential collaboration with academic groups • Study industry environment • Science of manufacturing

  14. Overall Approaches • Benchmarking • Quality systems • Standard setting • Audit/surveillance • Science review • Science of formulation development & manufacturing • Science of quality • Science of risk management

  15. Intermediate Step Evaluate the feasibility of establishing dedicated group of pharmaceutical inspectors

  16. Ongoing • New/Revised guidance documents • Re-evaluate & revise compliance programs • Education & training (industry & FDA) • New policies & procedures

  17. What do we hope to accomplish? • Demonstrate move to risk-based approaches • Demonstrate enhanced scientific base • Demonstrate better integration between submission review and inspectional programs • Demonstrate adoption of new technologies by industrial sector

  18. What do we hope to accomplish? • Immediate steps by Feb 03 • Two year project duration • Evaluation group being convened