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QbD / CMC Panel
Questions and Answers



                        1
When Will QbD Become a Requirement
      and How Will it be Enforced?
• FDA/GPhA has developed a QbD example for
  an IR product
• The draft QbD example for an MR product is to
  be completed by the end of 2010. Discussion
  with GPhA is expected in 2011
• The QbR questions will be revised in 2011 to
  incorporate QbD elements. Discussion with
  GPhA is expected in 2011 and 2012
• We expect that the revised QbR review system
  will be fully implemented by January 2013
                                                  2
Should Generic Applicants Expect to See
       a Concrete QbD Guidance?
• OGD will publish the revised QbR questions
• OGD will revise the frequently asked question
  paper to explain information that should be
  submitted to answer each question




                                                  3
How Does the FDA Propose Addressing
   the Incompatibility of “First to File" and
                    QbD?

• The FDA will publish a federal register notice to
  clarify ANDA submission requirements




                                                      4
Is OGD Open to Collaborative Discussion
          and Industry Input?
• Extensive discussion and input took place during
  the QbR development. OGD and GPhA
  collaborated in developing a QbD example for
  an IR product.
• The same approach will be used for developing
  the QbD example for an MR product and
  revising QbR questions
• It is important for ANDA applicants to review and
  provide comment to the QbD examples and QbR
  questions
                                                  5
Will There be Room for Discussion About
                   QbD?
• GPhA and OGD have organized three roundtable
  discussions in 2009 – 2010
• GPhA and OGD organized an QbD workshop in May
  2010
• GPhA and OGD will organize roundtable discussions on
  the QbD example for a MR product
• GPhA and OGD will organize QbR and QbD workshops
• Please be actively involved in any future roundtable
  discussions and workshops


                                                         6
What QbD Elements Are Required and
          What Are Optional?
• Required
  –   Quality target product profile (QTPP)
  –   Product design and understanding
  –   Process design and understanding
  –   Control strategy, including justification
• Optional
  – Design Space
  – Process Analytical Technology


                                                  7
How is the FDA Going to Handle the
   Different Interpretations of QbD by the
           Different Companies?
• OGD will use the same approach for all ANDAs
  regardless of applicants (companies)




                                                 8
Can FDA Clearly Define QTPP?
• QTPP – ICHQ8(R2) – “…forms the basis of
  design for the development of the product.”
  Considerations include:
  – Intended use, route of admin, dosage form, delivery
    system, strengths, container closure, release or
    delivery of active and attributes affecting PK, and
    quality criteria.
  – Simply stated – QTPP is predetermined set of targets
    based on the intended use of the product under
    development with respect to knowledge and
    characterization of the RLD                          9
Can FDA Clearly Define Critical
              Parameters?
• ICHQ8(R2)
  – A process parameter whose variability has an impact
    on a critical quality attribute and therefore should be
    monitored or controlled to ensure the process
    produces the desired quality.




                                                          10
Can FDA Clearly Define Prior Knowledge?

• OGD considers it as reliable information based
  on prior example of scientific studies. It could be
  internal to an applicant
• It should be reiterated again that generic
  industry needs to step up and provide practical
  examples




                                                    11
What Are OGD’s Expectations for Scored
               Tablets?
• Generic configuration is to be the same as the
  RLD
• Quality and Performance Expectations
  –   Suitability of splitting
  –   Uniformity
  –   Mass loss
  –   Suitable for intended use
• Development Studies
• Guidance under development
                                                   12

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Ucm237512

  • 1. QbD / CMC Panel Questions and Answers 1
  • 2. When Will QbD Become a Requirement and How Will it be Enforced? • FDA/GPhA has developed a QbD example for an IR product • The draft QbD example for an MR product is to be completed by the end of 2010. Discussion with GPhA is expected in 2011 • The QbR questions will be revised in 2011 to incorporate QbD elements. Discussion with GPhA is expected in 2011 and 2012 • We expect that the revised QbR review system will be fully implemented by January 2013 2
  • 3. Should Generic Applicants Expect to See a Concrete QbD Guidance? • OGD will publish the revised QbR questions • OGD will revise the frequently asked question paper to explain information that should be submitted to answer each question 3
  • 4. How Does the FDA Propose Addressing the Incompatibility of “First to File" and QbD? • The FDA will publish a federal register notice to clarify ANDA submission requirements 4
  • 5. Is OGD Open to Collaborative Discussion and Industry Input? • Extensive discussion and input took place during the QbR development. OGD and GPhA collaborated in developing a QbD example for an IR product. • The same approach will be used for developing the QbD example for an MR product and revising QbR questions • It is important for ANDA applicants to review and provide comment to the QbD examples and QbR questions 5
  • 6. Will There be Room for Discussion About QbD? • GPhA and OGD have organized three roundtable discussions in 2009 – 2010 • GPhA and OGD organized an QbD workshop in May 2010 • GPhA and OGD will organize roundtable discussions on the QbD example for a MR product • GPhA and OGD will organize QbR and QbD workshops • Please be actively involved in any future roundtable discussions and workshops 6
  • 7. What QbD Elements Are Required and What Are Optional? • Required – Quality target product profile (QTPP) – Product design and understanding – Process design and understanding – Control strategy, including justification • Optional – Design Space – Process Analytical Technology 7
  • 8. How is the FDA Going to Handle the Different Interpretations of QbD by the Different Companies? • OGD will use the same approach for all ANDAs regardless of applicants (companies) 8
  • 9. Can FDA Clearly Define QTPP? • QTPP – ICHQ8(R2) – “…forms the basis of design for the development of the product.” Considerations include: – Intended use, route of admin, dosage form, delivery system, strengths, container closure, release or delivery of active and attributes affecting PK, and quality criteria. – Simply stated – QTPP is predetermined set of targets based on the intended use of the product under development with respect to knowledge and characterization of the RLD 9
  • 10. Can FDA Clearly Define Critical Parameters? • ICHQ8(R2) – A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. 10
  • 11. Can FDA Clearly Define Prior Knowledge? • OGD considers it as reliable information based on prior example of scientific studies. It could be internal to an applicant • It should be reiterated again that generic industry needs to step up and provide practical examples 11
  • 12. What Are OGD’s Expectations for Scored Tablets? • Generic configuration is to be the same as the RLD • Quality and Performance Expectations – Suitability of splitting – Uniformity – Mass loss – Suitable for intended use • Development Studies • Guidance under development 12