Quality Systems and the Medical Product Review Process

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Quality Systems and the Medical Product Review
Process

• Janet Woodcock MD
• Director, CDER, FDA

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Improving Innovation in Medical Technology
Beyond 2002

• Key Area Instituting a continuous
  improvement/quality systems approach throughout
  premarket review
• What do we mean by this?

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Premarket Activities

• a review scientific assessment of submitted
  documents and data, with conclusions about
  conformance to scientific, technical and
  regulatory standards
• a review document written documentation of
  above

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Review Process Production Scale Activities

• New Drugs--
• Annual scientific reviews 21, 217
• Annual letters issued 2,500
• Generics
• Annual scientific reviews 5,000

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Review Process mass production!

• All must be scientifically correct, apply
  regulatory/scientific standards appropriately
• Subject to intense stakeholder and legal scrutiny
• Need to incorporate any new scientific findings
  or new regulatory guidance

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Assuring Quality of Scientific Activities

• Traditional craft or guild approach--
  hierarchical system of control
• Serial checking by successive levels of expertise
  or management
• 19th Century or earlier
• Most successful for one of a kind products
  

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Ensuring Consistent Quality in Mass Production
Evolution

• Standardization
• Quality control
• Quality assurance
• Quality systems
• Quality management

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Quality Systems

• Say what you do
• Do what you say
• Prove it
• Improve it

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Say what you do

• Identify Customers
• State Vision and Purpose
• Define Quality
• Define Quality Attributes
• Define Process

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Do what you say

• Quality Attributes Specifications
• Standards
• Quality control
• Process management
• Define process
• Standardize
• Track
• Control process

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Prove it

• Customer satisfaction
• Quality attributes level--trend analysis and
  metrics
• Process level--Audits and evaluation

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Improve it

• Corrective and Preventive Actions
• Feedback and training
• Organizational learning

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But, review is an intellectual activity...

• the review product is a scientific document...

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• How can this be reconciled with a quality system
  framework originating in mass manufacturing?

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Systems approach works well for many processes

• Being applied in health care, service delivery,
  administrative processing
• Variety of tools and methods that can be selected
  for specific application
• We are exploring examples of use in scientific
  activities

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CDER Situation

• Considerable work completed on process management
  aspects (procedures, training, tracking)
• Considerable work completed on work product
  standards (review templates)
• Some work on quality assurance/feedback
• Little on systems aspects such as peer discussion
  and assessment, CAPA, organizational learning,
  metrics

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Questions for committee

• Next presenters--examples of progress and
  proposals
• What steps are most important for integrating
  evolving science into review?