FDAs Pharmaceutical Quality Initiative Workshop - PowerPoint PPT Presentation

1 / 13
About This Presentation
Title:

FDAs Pharmaceutical Quality Initiative Workshop

Description:

Prior Scientific Knowledge / Data Mining ... Expansion of the Design Space to accommodate operations outside Design Space is ... Design Space Expansion Due to ... – PowerPoint PPT presentation

Number of Views:73
Avg rating:3.0/5.0
Slides: 14
Provided by: msuz8
Category:

less

Transcript and Presenter's Notes

Title: FDAs Pharmaceutical Quality Initiative Workshop


1
FDAs Pharmaceutical Quality Initiative Workshop
  • Breakout Session B
  • Product Process Development Design
  • for Biologicals and Biotech Products
  • March 2, 2007

2
FDAs Pharmaceutical Quality Initiative Workshop B
  • 1. QbDScientific Product / Process Design Space
  • Product / Process Cross Functional Teams in DEV
  • Dynamic process defines the product
  • As knowledge of activity based on protein
    structure increases, integrate cross functionally
    (include Quality)
  • Risks Raw Materials / Intermediates down
    stream effects
  • Risk Assessment CPQA CPP in Development
  • Discrimination High/Low Experts Risk
    Assessment
  • Product High Clinical / Experience Critical
    PQA
  • Process Parameters Critical PQA High PP (DOE)
    CPP
  • Critical Process Parameters 80/20 80/16/4
  • Critical Product Quality Attributes - 1st
  • Critical Process Parameters 2nd
  • Design Space Definition Iterative CPQA / CPP

3
FDAs Pharmaceutical Quality Initiative Workshop B
  • 2. Design Space
  • Determination of Design Space
  • Prior Scientific Knowledge / Data Mining
  • Designed Experiments (small scale DOE) Critical
    Product Quality Attributes / CPPs
  • Animal Models
  • Clinical Performance (may be limited for CPP)
  • Clinical Databases (across similar products -
    MAbs)
  • Design Space knowledge can be a starting point
    for extending CPQA / CPPs across products /
    platforms
  • CPPs are the foundation for validation

4
FDAs Pharmaceutical Quality Initiative Workshop B
  • 3. Quality System
  • Quality System is Essential Q10
  • Quality Unit involved in Development
  • Distinction between quality concepts and Quality
    Unit
  • Quality Approval of DEV Plan Gate Reviews
  • Double Handshakes Throughout Development
  • Knowledge Management System
  • Right Approach at the Right Time
  • Lab Notebooks vs. Formal Protocols
  • Development Reports
  • Tiered approach to details (various levels of
    summary data)
  • Sophisticated IT Systems
  • Dont rely on Tribal Knowledge
  • Relational Databases

5
FDAs Pharmaceutical Quality Initiative Workshop B
  • 4 . Industry Communications to FDA
  • Development Summary Report
  • Risk Assessment Summaries
  • Critical vs Non-critical rationale CPQA / CPP
  • DOE Results in support of CPPs
  • CPQAs in the Development Section
  • CPPs in the Manufacturing Section
  • Upfront Agreement FDA / Industry
  • Design Space Definition
  • QbD Pilot Program Requirements
  • MAb Platform Design Space Master File
  • Comparability Protocols-Process/Facility Changes
  • PAI Inspection Expectations

6
FDAs Pharmaceutical Quality Initiative Workshop
  • Breakout Session H
  • Process Control Post-Approval Product Life
    Cycle
  • for Biologicals and Biotech Products
  • March 2, 2007

7
FDAs Pharmaceutical Quality Initiative Workshop H
  • 1. QbD Application Post-approval
  • Design Space is a living document
  • Design Space should be periodically reviewed as
    part of the Quality System
  • Risk Assessment and growing knowledge should be
    used as a tool to update the Design Space
  • Donnas Humpty Dumpty approach to Design Space
  • Design Space is the Egg
  • Control Space is the Yolk

8
FDAs Pharmaceutical Quality Initiative Workshop H
  • 2. Design Space Expansion Due to Experience
  • Design Space is dynamic, a living document and
    needs to be updated based on new experience and
    may be expanded (FDA approval)
  • Additional experience may find new control
    parameters
  • Failures and investigation reports could be
    included in the update of Design Space
  • Operations can be adjusted within the Design
    Space
  • Expansion of the Design Space to accommodate
    operations outside Design Space is considered to
    be a change and needs to be reported to FDA
    appropriate experimentation / knowledge would be
    needed by firms to expand Design Space for FDA
    approval

9
FDAs Pharmaceutical Quality Initiative Workshop H
  • 2. Design Space Expansion Due to Experience
    Contd
  • Control Space is where, within the Design Space,
    a firm would normally operate operations outside
    the Operating Space but within the Design Space
    should be investigated but not reported to FDA as
    is currently done in validated processes
  • Based on additional knowledge defining a robust
    Design Space, tests may be eliminated and
    specifications modified with FDA agreement
  • It is comforting to Industry to report changes
    within the Design Space to FDA

10
FDAs Pharmaceutical Quality Initiative Workshop H
  • 3. QbD Applied Across Product Class/Platform
  • Super Design Space capture family or platform
  • Concept Universal Platform Approach
  • Potential for restricted Design Space
  • Utilization of previous knowledge
  • Platform
  • Some data still needed
  • Risk assessment specific to product
  • Certain vaccines have one process with multiple
    strains running across one platform
  • Case-by-case
  • MOA
  • Characterization
  • Process
  • Patient specific drugs ultimate robust Design
    Space

11
FDAs Pharmaceutical Quality Initiative Workshop H
  • 4. QbD Implementation
  • Comparability Protocols
  • Change Design Space because of new facility or
    different scale Comparability Protocol needs to
    be updated
  • Unit Operations Design Space easier step approach
  • Process Capability and clinical experience
    determines Design Space
  • Shrinking the Design Space because process is
    less robust is a dilemma for regulatory reporting

12
FDAs Pharmaceutical Quality Initiative Workshop H
  • 4. QbD Implementation
  • How do we deal with the uncertainty in Design
    Space development? Well deal with it the same
    way we dealt with it without Design Space
  • Can data from monitoring and control within the
    Design Space be used to eliminate a specification
    without the requirement to submit a Comparability
    Protocol ?
  • Use of deviation reports (with appropriate
    additional experimentation) to expand the Design
    Space
  • Leverage 20 years of data, at set point, to
    define (a very narrow) Design Space

13
FDAs Pharmaceutical Quality Initiative Workshop H
  • 5. QbD Reduction of Regulatory Supplements
    YES !
  • Current Operational Regulatory Mechanisms
  • Comparability Protocols
  • Principles are the same for all categories but
    vastly different scope of scientific data
  • Cell lines new IND ?
  • Unit operations
  • Process parameters
  • Raw materials
  • Unit Operations Design Space
  • Quality Attributes Specific to Unit Op
  • Plus Linkage to Downstream Unit Ops
  • Some Aspects of Design Space are specific to
    equipment and facility
Write a Comment
User Comments (0)
About PowerShow.com