Risk-Based cGMPs: Defining Risk and Quality

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Risk-Based cGMPs Defining Risk and Quality

• Summary of Stakeholder Comments
• April 23, 2003

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Definition of Risk

• No consensus reached
• FDA and industry do perform risk assessments
  routinely but few employ a formalized risk
  assessment and management process
• Definition may need to be product specific
• Risk changes through product life cycle
• Types of risks identified include
• Patient
• Business
• Regulatory

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Points to Consider in Defining Risk

• Benefits comparison
• Product availability
• Quality systems
• Product development knowledge
• Probability and severity of hazard
• Acceptable levels of risk
• Patient population (age, condition, species)
• Number of products made at a given site
• Exposure (volume of products in commerce)
• Dosage form
• Process step

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Definition of Quality in the Context of Mfg
Control of Products

• Fitness for intended use
• Safe
• Effective
• Available
• Consistency
• Process
• Product
• Increased process and product knowledge leads to
  increased assurance of quality
• Must include customer (patient) expectations

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Benefits of a Risk Based System

• Patients
• Increased availability
• Faster approval of new products
• Continue to receive quality products
• FDA
• More product and process knowledge shared by
  industry
• More efficient resource allocation for review and
  inspection
• Increased trust and understanding of industry
  decision making

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Benefits of a Risk Based System

• Industry
• Fewer, more efficient, science based inspections
  resulting in increased consistency
• Faster, more consistent reviews
• Potential for reduced regulatory burden
• Manage changes and nonconformance with less FDA
  oversight
• Focuses resources on critical issues
• Flexibility to focus on what should be done, not
  what can be done
• Improves communication with FDA

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Challenges

• Major cultural change for both FDA and industry
• Trust
• Who will make the first move to drive this
  process

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Challenges

• Developing a common understanding of risk and
  risk assessment
• Principles and minimum standards
• Risk assessment and management training
• Communication to and perception by other
  stakeholders (public, Congress)
• Communication within FDA
• Completion of master plan (timeline)
• Perceived risk of development report review

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Existing systems

• Medical devices
• Foods (HACCP)
• EPA
• Insurance industry
• Well characterized biologics
• EU and HealthCanada initiatives
• Deviation reports
• Annual product review
• Recall, field alerts
• Change control

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Sector Specific Issues

• Different cGMPs for animal products
• Differences for animals in the food chain
• Lot release of certain biologics

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Next Steps

• Evaluate existing systems to develop general
  principles of risk management
• Additional work required to define risk and
  quality in the context of risk based GMPs
• Complete and share master plan
• Global harmonization
• Increasing self regulation