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PAT Progress Report: 13 April 2004 ACPS Meeting

PAT Progress Report: 13 April 2004 ACPS Meeting . Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science CDER, FDA. Outline. Brief history Current Status and Next Steps Finalizing PAT Guidance, Training and Certification Chris Watts Standards development Ali Afnan

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PAT Progress Report: 13 April 2004 ACPS Meeting

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  1. PAT Progress Report: 13 April 2004 ACPS Meeting Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science CDER, FDA

  2. Outline • Brief history • Current Status and Next Steps • Finalizing PAT Guidance, Training and Certification • Chris Watts • Standards development • Ali Afnan • Rapid microbial methods • Brian Riley • Committee discussion and recommendations • Are we on the right track? • Any recommendations to improve our approach?

  3. Historical Milestones • October 1993, St. Louis, Missouri • Pharmaceutical Process Control and Quality Assurance by Non-traditional Means (AOAC Symposium) • February 2000, San Francisco, California • FIP’s Millennium World Congress of the Pharmaceutical Sciences • March 2001, London, United Kingdom • RPS NTF#4: Process Measurement and Control

  4. The message has not changed! FIP Millennium Conference San Francisco

  5. The message has not changed! FIP Millennium Conference San Francisco

  6. G.K. Raju, MIT and CAMP ACPS Meeting November 28, 2001

  7. February 25-26, 2002 June 12-13, 2002 October 23, 2002 ACPS Meeting November 28, 2001

  8. Tom Layloff, PAT Sub-Committee Acting Chair Arthur H. Kibbe, Acting Chair PAT Application Benefits Working Group      Judy P. Boehlert, Acting Chair PAT Product and Process Development Working Group     Leon Lachman, Acting Chair PAT Process and Analytical Validation Working Group     Melvin Koch, Acting Chair PAT Chemometric Working Group

  9. FDA Sci Board, April 9, 2002 Ray Sherzer Dr. Woodcock

  10. Quality of Relationship Quality of Thinking Quality of Results Quality of Action The PAT Team: The Engine of Success A team is a group of interdependent individuals with complimentary skills who are organized and committed to: 1. Achieving a common purpose 2. Applying a common process, and 3. Sharing a common destiny

  11. PATRIOT: ORA, CDER & CVM PAT Steering Committee Doug Ellsworth, ORA/FDA Dennis Bensley, CVM/FDA Mike Olson, ORA/FDA Joe Famulare, CDER/FDA Keith Webber, CDER/FDA Frank Holcomb, CDER/FDA Moheb Nasr, CDER/FDA Ajaz Hussain Chair, CDER/FDA • PAT Review - Inspection Team • Investigators: • Robert Coleman (ORA/ATL-DO) • Rebeca Rodriguez (ORA/SJN-DO) • Erin McCaffery (ORA/NWJ-DO) • George Pyramides (PHI-DO) • Dennis Guilfoyle (ORA/NERL) • Compliance Officers: • Albinus D’Sa (CDER) • Mike Gavini (CDER) • William Bargo (CVM) • Brenda Uratani (CDER) • Reviewers: • Norman Schmuff (CDER) • Lorenzo Rocca (CDER) • Vibhakar Shah (CDER) • Rosario D’Costa (CDER) • Raafat Fahmy (CVM) • Brian Riley (CDER) PAT Policy, Consultant, Support Team Raj Uppoor, OPS/CDER Chris Watts, OPS/CDER Huiquan Wu, OPS/CDER Ali Afnan, OPS/CDER PAT Training Coordinators John Simmons, Karen Bernard and See Lam

  12. Current State • Several successful workshops (e.g., AAPS Arden House, IFPAC, ISPE, PDA,…) • Several proposals, one approval • First training session complete, certification process ongoing • Ongoing Interagency Agreement with NSF • Ongoing CRADA with Pfizer on Chemical Imaging • Ongoing communication and cooperation with other regulatory agencies (e.g., EMEA PAT Team, Health Canada, MHLW)

  13. Current State • ASTM Committee E55: Pharmaceutical Applications of PAT (http://www.astm.org) • Growing external collaborations and emerging support structure • ISPE and PDA interest in PAT, PAT Group in AAPS, discussion on AAPS-ISPE collaboration,, strong support from IFPAC and formation of IPFACMA or IFPATMA, AIChE,… • Growing number of academic programs with focus on PAT • Several “PAT” companies and training opportunities • Pharmacopeias are interested in PAT • PAT now a part for the 21st Century Initiative and FDA’s Strategic Plan

  14. Next Steps • Final Guidance • Quality System for PAT process • Participate in ASTM • Expand the scope of the guidance to include Office of Biotechnology Products OPS/CDER (discussions today) • They were not part of the first training and certification program • Develop 2nd Training and certification program • In the next 2-3 years PAT is a regular part of the CMC & GMP program

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