FDAs Pharmaceutical Quality Initiatives Implementation of a Modern Riskbased Approach Cosponsored wi

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FDAs Pharmaceutical Quality Initiatives
Implementation of a Modern Risk-based
ApproachCo-sponsored with AAPS, ISPE, FDA
February 28, 2007 to March 2, 2007 Modern
Approach to Process Validation

• Moderators
• Musa Ghannam, Ph.D.
• Brian Hasselbalch
• Christine Moore, Ph.D.

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Breakout Session Outline

• Brief Introduction
• Discussion Questions
• Wrap-up and Summary

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Validation Defined

• Validation means demonstrating process control
  and reproducibility with a high degree of
  assurance before introducing product to the market

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Traditional Process Validation
3 Conformance Batches
Commercial Production
Process Changes Prospective Improvements Manufactu
ring Flexibility Performance Shifts OOS Reactions
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Paradigm Shift

• Process Validation ? 3 Discrete Batches (Only)
• Process Validation ?

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Commercial Manufacturing

• On-going data collection through
• Quality programs
• PAT applications
• Statistical analysis
• Continually enhance process understanding
• Continually evaluate sources of variability
• Develop a more complete assessment of process
  robustness

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Tools Related Topics

• Quality by Design
• Risk Assessment Management Techniques
• PAT
• Statistical Evaluations of Process

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Benefits

• Increased process understanding
• Decreased process variability
• Measuring product quality and adjusting process
  real-time
• Less reliance on end product testing
• Improved process robustness

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Questions/Discussion Points

• How do we determine the type and amount of
  information that will provide sufficient
  assurance to permit commercial batches to be
  released to the market?
• How can a validation program be structured to
  reflect the level of process understanding and
  the degree of confidence in the design space?
  How might the validation program change as
  process knowledge and understanding increases?
• Should the validation program apply to changes
  within a design space? How might it differ than
  for changes outside of the design space?
• How should risk management be incorporated into
  the validation lifecycle approach?