ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE March 13, 2003

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Presented at the Advisory Committee for
Pharmaceutical Science meeting on March 13,
2003 by Helen Winkle
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ADVISORY COMMITTEE FOR PHARMACEUTICAL
SCIENCEMarch 13, 2003

• DRUG PRODUCT QUALITY
• Pharmaceutical cGMPs for the 21st Century

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Goals of Drug Quality Initiative

• Incorporate concepts of risk management and
  quality systems
• Include latest scientific advances in
  manufacturing and technology
• Better integrate the review program with the
  inspection program
• Ensure consistency in standards
• Encourage for innovation in manufacturing
• Focus resources effectively to address most
  significant health risks

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Overview

• Applies to pharmaceuticals, biological human
  drugs and veterinary drugs
• Focus is on review of drug product applications
  and inspection of manufacturing facilities
• Initiative being coordinated through steering
  committee with members from ORA, CBER, CVM, CDER,
  OC and input from CDRH and CFSAN
• Initiative will take two years
• Already provided six month report - 2/20

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Using state-of-the-art approaches to our review
and inspection processes means getting important
new medications to patients fasterFDA will
focus our attention and resources on the areas of
greatest risk, with the goal of maximizing public
health protection without impeding innovation
Mark McClellan, MD
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Task Groups
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Contracts Management

• Expedite external studies of key issues to be
  addressed under the initiative
• Looking at two areas
• Effective Quality Systems Practices
• cGMP and Other Product Quality Assurance
  Methodology
• Other areas of support for initiative

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International

• Important to have harmonized approaches to
  assuring drug product quality
• Work with ICH specifically in the realm of
  technological advances
• Look at other forums for harmonization
• Benchmark with other country systems

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Part 11

• Clarify the scope of FDAs electronic
  recordkeeping requirements
• Provide for enforcement discretion in the areas
  where interpretation is unclear
• Withdrawal draft guidance (2/4)
• Webcast
• Amend 21 CFR Part 11 Rule and Preamble

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Dispute Resolution

• Develop consistent policies and procedures for
  resolving scientific and technical cGMP issues
• between regulated industry and the FDA
• between components within FDA

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483 Communications

• Honing language to communicate deficiencies
  observed during cGMP inspections
• Combined with Dispute Resolution

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Warning Letter

• Launching a program to identify any
  inconsistencies across program areas with respect
  to all drug cGMP warning letters

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Manufacturing Science

• Ensure high efficiency and quality of
  pharmaceutical manufacturing and associated
  regulatory processes
• Facilitate introduction of modern manufacturing
  technologies and systems
• Enhance FDA expertise in pharmaceutical
  engineering and technologies
• PAT initiative

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Changes Without Prior Review

• Identify opportunities to allow post approval
  manufacturing changes without FDA review and
  approval prior to implementation
• Comparability protocol
• Discussed yesterday

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Risk Management Workplanning

• Ensuring systematic risk management approaches
• Implement risk-based approaches that focus both
  industry and FDA attention on critical areas
• Recent reorganization of CDERs Office of
  Compliance

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Pharmaceutical Inspectorate

• Enhance the Agencys expertise in pharmaceutical
  technologies
• Ensure state-of-the-art pharmaceutical science
• Hire staff that has needed expertise
• Establish a closer working relationship between
  field and centers

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Product Specialist

• Develop highly trained FDA product specialists to
  help in strengthening consistency in regulatory
  decisions and ensure submission reviews and cGMP
  inspections are coordinated and synergistic

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Team Biologics Operations

• This initiative had already been started
• Improve operations of Team Biologics building on
  implementation of quality management system
• CDER/CBER consolidation will affect how some of
  Team Biologics is handled

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Quality Systems

• Looking at both internal and external quality
  systems
• Improve both review and inspectional processes
  through implementing quality systems approach
• Look at regulation

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Training

• Affects all areas
• Still being developed but expect extensive
  training program both for internal and external

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Evaluation

• Extremely important part of the initiative
• Must develop appropriate metrics and mechanism
  for evaluation of the total initiative

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Next Steps

• Workshop - April 22-24
• Possible vetting of manufacturing science
  questions before advisory committee
• Several draft guidances to issue for public
  comment
• Comparability protocol
• Dispute resolution
• Additional workshops to focus on science
• Part 11 clarification