1. Standards Development for PAT Ali Afnan Process Analytical Technologist Office of Pharmaceutical Science, CDER, FDA Rockville, Maryland

2. 2 Outline  Why use consensus standards  What is ASTM  History of Committee  Committee Organization  Committee Officers  Sub-committee Officers

3. 3 Why use the consensus standards process for PAT  Involvement of all interested parties  Balanced discussion  Due process  NTTAA (The National Technology Transfer And Advancement Act (Public Law 104-113) mandates that Federal departments and agencies use voluntary consensus standards in place of Government standards wherever practical. Government employees serve on standards committees. Their names and contact information must be accessible by the public.)

4. 4 ASTM  ANSI accredited standards development organization  >100 years of experience in standards development  Recognized developer of international standards  Offices in W. Conshohocken, PA

5. 5 History of Development of the Committee  Winter and Spring 2003 – FDA meets with ASTM re development of a new Committee for PAT  October 2003 – PAT Committee Planning Meeting @ ASTM  December 1, 2003 - Organizational Meeting at ASTM  January 2004 - Nomination and Election of Committee Officers  February 11-12, 2004 – 1 st meeting of ASTM E55  Next meeting – 18-20 May, Salt Lake City

6. 6 Committee E55 on Pharmaceutical Application of Process Analytical Technology - Scope The scope if the Committee shall be development of standardized nomenclature and definitions of terms, recommended practices, guides, test methods, specifications, and performance standards for pharmaceutical application of process analytical technology. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

7. 7 Committee E55 Organization  E55.01 PAT Systems Management  E55.02 PAT Systems Implementation & Practice  E55.90 Executive Subcommittee  E55.91 Terminology

8. 8 Committee E55 Elected Officers  Chairman: Don Marlowe, US FDA  Vice Chairman: Ray Scherzer, GSK  Membership Secretary: James Drennen, Duquesne University  Recording Secretary: Gawayne Mahboubian-Jones, Optimal Industrial Automation, Ltd

9. 9 Sub-Committees’ Officers  E55.01 (PAT Systems Management) Chairman: Ken Leiper, Benson Associates Vice Chairman: Gerry Migliaccio, Pfizer Secretary: Chris Watts, FDA  E55.02 (PAT Systems Implementation & Practice Chairman: Ferdinando Aspesi, Aventis Vice Chairman: Bob Chisholm, AstraZeneca Secretary: Ali Afnan, FDA  E55.91 (PAT Terminology) Chairman: Larry Hecker, Abbott Secretary: Jim Fox, GSK