Pat progress report 13 april 2004 acps meeting
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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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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

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?


Historical milestones

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


Pat progress report 13 april 2004 acps meeting

The message has not

changed!

FIP Millennium Conference

San Francisco


Pat progress report 13 april 2004 acps meeting

The message has not

changed!

FIP Millennium Conference

San Francisco


Pat progress report 13 april 2004 acps meeting

G.K. Raju, MIT and CAMP

ACPS Meeting November 28, 2001


Pat progress report 13 april 2004 acps meeting

February 25-26, 2002

June 12-13, 2002

October 23, 2002

ACPS Meeting November 28, 2001


Pat progress report 13 april 2004 acps meeting

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


Pat progress report 13 april 2004 acps meeting

FDA Sci Board, April 9, 2002

Ray Sherzer

Dr. Woodcock


The pat team the engine of success

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


Patriot ora cder cvm

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


Current state

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)


Current state1

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


Next steps

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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