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Quality by Design & Question-Based Review: Observations by the Generic Pharmaceutical Industry. Advisory Committee for Pharmaceutical Science October 5, 2006 Gordon Johnston Generic Pharmaceutical Association. Outline. Introduction Quality by Design Question-Based Review Summary.

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quality by design question based review observations by the generic pharmaceutical industry

Quality by Design & Question-Based Review: Observations by the Generic Pharmaceutical Industry

Advisory Committee for Pharmaceutical Science

October 5, 2006

Gordon Johnston

Generic Pharmaceutical Association

outline
Outline
  • Introduction
  • Quality by Design
  • Question-Based Review
  • Summary
introduction
Introduction
  • QbD/QbR
    • Requires significant changes to cross-functional coordination within firms
    • Shift to QbR content represents a major change
      • Cautiously optimistic
      • A steep learning curve for industry
      • Conversion to CTD format
      • Aggressive implementation schedule by FDA
      • ~ 800 ANDAs expected in CY 2006
    • Increased burden for industry
quality by design
Quality by Design
  • Extensive manufacturing expertise in the industry
    • Generic firms often manufacture 50 - >100 products
    • Product and process understanding is critical for efficiency
  • Concepts of QbD have been in use by industry for many years
    • QbD represents a more organized and integrated approach to product development
quality by design1
Quality by Design
  • Opportunities
    • Value in ‘prior knowledge’
    • Extensive experience with common formulations
      • Excipient properties well understood
      • Critical attributes impacting manufacturing process known
quality by design2
Quality by Design
  • Opportunities (cont’d)
    • Keen knowledge of equipment and common manufacturing processes
      • Blending, coating, etc.
    • Potential for reduced review time
    • Potential for reduced post-approval burden
quality by design3
Quality by Design
  • Are QbD expectations clearly defined?
    • GMP implications?
      • Experience to date is mixed
      • ICH Q8 concepts still being integrated by Field
      • Field often expects full design space validation
      • Prior knowledge not universally accepted by investigators at this time
quality by design4
Quality by Design
  • Should FDA modify its focus?
    • Generic industry still required to accept FDA dissolution specifications
    • Continued requirements to set specifications typically based on process capabilities and not product performance
      • For example, residual solvents
    • More guidance on non-oral dosage forms needed
question based review
Question-Based Review
  • Represents a tool to efficiently assess QbD approach
  • Industry is supportive of the initiative
  • Industry and OGD still learning
question based review1
Question-Based Review
  • OGD Model QOS
    • 2 years in the making
    • Open dialogue between OGD and generic industry during evolution
    • OGD responsive to Q&A sessions
question based review2
Question-Based Review
  • OGD Model QOS
    • OGD-industry collaboration has accelerated industry’s understanding of QbR
    • Ongoing communication critical during full implementation
question based review3
Question-Based Review
  • OGD Model QOSs
    • Help industry recognize issues OGD generally considers critical
    • Guide industry toward quality by design
    • Assist industry to prepare a high quality QOS
question based review4
Question-Based Review
  • OGD Questions
    • Allow industry to address some questions with prior knowledge
    • Industry has been active in submitting QbR applications
      • Over 35 ANDAs
      • First ANDA Approval last month
question based review5
Question-Based Review
  • Challenges
    • Simultaneous conversion to CTD format and QBR data elements
    • Implementation schedule has been challenging for some companies
      • Some companies have been submitting QbR applications since this summer
    • Substantial internal training and coordination required for implementation
question based review6
Question-Based Review
  • Challenges
    • Still uncertain on OGD expectations for QOS and product development reports
    • Oct 20 OGD training on how to prepare a high quality QOS
      • Initial response is very positive
    • More OGD training if needed
question based review7
Question-Based Review
  • Recommendation
    • Post-approval reduction in regulatory burden?
      • Industry requests clarity on types of supplements where regulatory burden may be ‘downgraded’
    • Extending QbR concept to already approved products (>8000)?
    • Extending QbR concept to drug substance DMF
summary
Summary
  • Excellent communications by OGD
    • Numerous meetings, webcasts, teleconferences during development phase of QbR
    • Ongoing industry-OGD communications critical
  • Increased burden
summary1
Summary
  • Need to expand QbR to already approved ANDAs and drug substance DMF
  • Post-approval regulatory relief a critical outcome of initiative
  • Industry remains cooperative and hopeful
  • Reassess in a year