SQA Task Force for Modernization of the FDA GLPs

1. SQA Task Force for Modernization of the FDA GLPs Nancy Gongliewski

2. 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

3. 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 A&M) 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 O�Brien 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. SQA�s 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

11. 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 O�Shaughnessy, FDA , GLP Modernization Group Linda Tollefson RADM, Asst Commissioner for Science, FDA Vernon Toelle, FDA CVM Robert Cypher, EPA, OECA John Helm, EPA, OECA

12. FDA�s 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

13. 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?�

14. FDA Progress on Modernization so Far FDA�s GLP Working Group formed with Dr. Viswanathan as the Chairperson Each center has provided input on how the use the regulation, what work, what doesn�t Agency has also received input from industry and PhRMA, and will likely request input from universities

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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