Advisory Committee for Pharmaceutical Science October 19, 2004 INTRODUCTION

1
Advisory Committee for Pharmaceutical
ScienceOctober 19, 2004INTRODUCTION
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Welcome

• Members
• Perspective new members
• SGEs
• Chair

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Agenda for Meeting

• Update on OPS and CGMP Initiative for 21st
  Century
• Updates on subcommittee and working groups
• Critical Path Initiative and what it means to OPS
  in the future
• Manufacturing - Moving Toward Desired State
• Discussion on Bioequivalence Issues
• Recommendations
• New topic

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OPS in 2005

• Doing core business
• Streamlining review processes and incorporating
  best practices
• Pursuing next steps in Pharmaceutical Quality
  Initiative
• Supporting Critical Path Initiative
• Further integrating biotech products
• Determining regulatory issues regarding follow-on
  proteins

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CGMP Initiative for the 21st Century Goals -2002

• Incorporate the most up-to-date concepts of risk
  management and quality systems approaches
• Encourage latest scientific advances in
  pharmaceutical manufacturing and technology
• Ensure submission review program and the
  inspection program operate in a coordinated and
  synergistic manner
• Apply regulation and manufacturing standards
  consistently
• Encourage innovation in the pharmaceutical
  manufacturing sector
• Use FDA resources most effectively and
  efficiently to address the most significant
  health risks

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Accomplishments

• Part 11
• clarify scope and application of Part 11
• 2 guidances
• Technical dispute resolution process
• draft guidance
• 12 month pilot program
• Drug CGMP warning letters
• review by centers
• ensuring scientific input
• International collaboration
• ICH
• PIC/S

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Accomplishments

• Facilitating innovation (standards and policies)
• Aseptic processing guidance
• PAT
• Guidance
• Team
• ASTM E55
• Comparability protocol
• Manufacturing science
• Desired state
• Continuous improvement
• Reduction of variability

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Accomplishments

• Product specialists
• Team approach
• Best practices from PAT team and Team-Biologics
• Integration of preapproval and inspection
• Pharmaceutical Inspectorate
• Changes in PAI program
• Quality management systems
• Standard quality systems framework for FDA
• Quality systems guidance - meeting requirements
  of CGMP
• GMP harmonization analysis
• Process validation
• Good guidance practices

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Accomplishments

• Risk Management
• Site selection model for inspection
• Other
• Team Biologics
• Number of initiatives underway
• Adoption of quality systems approach
• Evaluation of initiative

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Next Steps in Product Quality Initiative

• Continue efforts
• Council on Pharmaceutical Quality
• Focus on manufacturing science and reaching
  desired state - look to answer questions
• Implement quality systems approaches
• Finalize guidances
• Get dispute resolution process finalized
• Continue ICH negotiations on Q8 and Q9 and pursue
  Q10