SQA Task Force for Modernization of the FDA GLPs

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SQA Task Force for Modernization of the FDA GLPs

• Nancy Gongliewski

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Background

• FDA contacted SQA to request input on
  modernization to FDA GLPs
• SQA formed an eight member task force to study
  potential changes to GLPs
• The Task Force requested and received input from
  SQA at large
• The Task Force met by teleconference and face to
  face

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SQA Task Force

• Nancy J Gongliewski, Task Force ChairSQA GLP
  Specialty Section Chair, Industry perspective
  (GlaxoSmithKline)
• Matthew (Matt) Foster, RQAP-GLPSQA FDA Liaison,
  CRO perspective (MPI Research)
• James (Jim) Ault, RQAP-GLP, RACSQA Board member,
  CRO perspective (Ricerca Biosciences)
• Debra Ann Bridges, RVT, RQAP-GLPSQA Med Devices
  Specialty Section University perspective (Texas
  AM)
• Deborah Eyer Garvin, RQAP-GLPSQA Past President,
  Consultant perspective (WCQTI/Pacific Rim
  Consulting Inc)
• Anthony (Tony) B JonesSQA Regulatory Forum
  Chair, Bioanalytical CRO perspective (Taylor
  Technology)
• Patricia OBrien Pomerleau, RQAP-GLPSQA Past
  President, CRO perspective (The Hamner
  Institutes, formerly CIIT)
• John D Yergler, RQAP-GLPSQA Past President,
  Consultant perspective
• James McCormack, SQA Board liaison

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SQA Task Force

• SQA Task Force members general conclusions
• Major changes to the regulation may not be
  necessary as the regulation covers the basics and
  allows flexibility in application under varying
  circumstances
• GLPs contain elements of a Quality Management
  System

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SQA Task Force Recommendations

• Include efficacy studies of bioterrorism agents
  in the GLP scope
• Definition and roles and responsibilities of
  Individual Scientists
• Specify Testing Facility Management
  Responsibilities
• Establishment of archive
• Ensure maintenance of master schedule

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SQA Task Force Recommendations

• Specify the names, addresses and delegated
  activities of Individual Scientist's involved in
  the study
• Specify Study Conduct
• SOP and protocol deviations shall be reported to
  Study Director in a timely manner
• Specify contents of reports from Individual
  Scientists

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SQA Task Force Recommendations

• Specify process for terminated or discontinued
  studies
• Modify Retention of Records requirements
• Specify protocol inclusion
• Relocate retention of master schedule, away from
  QAU
• Specify process when Sponsor goes out of business
  or transfers ownership

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SQA Task Force Recommendations

• Remove sheet from master schedule references
• Eliminate requirement for retention of test
  article containers
• Remove requirement for QAU to maintain master
  schedule and retain copies of protocol

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SQA Task Force Recommendations

• Modernize the examples in the definition of raw
  data to include electronic records
• QAU
• Specify that protocol copies only be maintained
  until issuance of final study report
• Clarify wording regarding QAU review of final
  report and data
• Include computerized systems in equipment section
  

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SQAs Request for Guidance

• Use guidance to capture current agency
  expectations on certain topics, for example
• Multi-site study best practices
• Test and control article characterization
• GLP compliance expectations in academic settings
• Method validation best practices
• Application of GLPs to Medical Device studies
• Roles and responsibilities of Sponsors
• Processes around contributing scientists reports
• Appropriate use of process inspections by the QAU

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Meeting with the FDA

• Participants
• Task Force Members
• Agency Members
• CT Viswanathan, Assoc Director of DSI, CDER, and
  Chair of the GLP Modernization Working Group
• Jackie OShaughnessy, FDA , GLP Modernization
  Group
• Linda Tollefson RADM, Asst Commissioner for
  Science, FDA
• Vernon Toelle, FDA CVM
• Robert Cypher, EPA, OECA
• John Helm, EPA, OECA

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FDAs Objectives for Modernizations

• To encourage development of science based
  policies
• To encourage the use risk based approaches
• To ensure adoption of quality management
  practices
• To ensure consistent enforcement of GLPs across
  all FDA centers

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Dr. Viswanathan

• This is a global effort and is not about making
  point changes in the GLP regulations. We are
  very open to the extent of change there are no
  constraints at this time.
• We need input at a high level to answer these
  types of questions
• What are the essential quality control points?
• Will the regulation hold up for another 10
  years?

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FDA Progress on Modernization so Far

• FDAs GLP Working Group formed with Dr.
  Viswanathan as the Chairperson
• Each center has provided input on how the use the
  regulation, what work, what doesnt
• Agency has also received input from industry and
  PhRMA, and will likely request input from
  universities

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FDA Points to Consider and Task Force Discussions

• Descriptive (prescriptive) nature of the GLPs
• Is there too much detail?
• A perception that there is too much detail may be
  due to a lack of understanding of the regulation

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FDA Points to Consider and Task Force Discussions

• Responsibilities/relationship of the study
  director and management
• Dose formulation analysis is often missing
• FDA believe that the dose concentration needs to
  be known prior to dosing
• Handling situation may be complicated by the
  Sponsor/Study Director relationship
• Should the Sponsor be given more responsibility
  to provide Study Director with more information

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FDA Points to Consider and Task Force Discussions

• Leveraging the QAU
• If using a Quality System approach, the FDA will
  need a way to assess the effectiveness of the QAU
  
• Is there a way to measure the performance of QAU
  without providing the agency with the QAU
  inspection reports i.e. a summary report
• Some Task Force member suggested that if the
  agency routinely reviewed QAU inspection reports,
  the ability to self monitor would be impaired and
  inspection findings may not be candidly reported
  

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FDA Points to Consider and Task Force Discussions

• Contributing Scientists Reports
• Should these reports remain separate?
• The consensus among both FDA and Task Force
  members was that these reports should remain
  separate

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FDA Points to Consider and Task Force Discussions

• FDA stakeholders, including SQA, have advocated
  harmonization with OECD concerning multi-site
  studies
• FDA will consider this item

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FDA Points to Consider and Task Force Discussions

• Issues with GLP application in an academic
  setting
• Lack of rigor
• Lack of awareness
• SQA believes that universities are capable of
  performing work to GLP standards and that GLPs
  should not be waived in these circumstances

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Next Steps

• FDA GLP Modernization Working Group is finishing
  input collection
• FDA will meet with agency working group and
  management soon
• FDA Modernization Working Group will begin task
  of deciding how to modernize the GLPs
• FDA will publish preliminary information to the
  public
• FDA may conduct public workshop
• A new GLP regulation may emerge