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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. Janet Woodcock, MD Director, Center for Drug Evaluation and Research Food and Drug Administration October 25, 2002. Agenda. What is the initiative about? Background Major themes/principles

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

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  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

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