Standards Development for PAT

Ali AfnanAli AfnanProcess Analytical TechnologistProcess Analytical Technologist

Office of Pharmaceutical Science, CDER, FDAOffice of Pharmaceutical Science, CDER, FDA

Rockville, MarylandRockville, Maryland

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Outline

Why use consensus standards What is ASTM History of Committee Committee Organization Committee Officers Sub-committee Officers

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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.)

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ASTM

ANSI accredited standards development organization

>100 years of experience in standards development

Recognized developer of international standards

Offices in W. Conshohocken, PA

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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 – 1st meeting of ASTM E55

Next meeting – 18-20 May, Salt Lake City

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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.

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Committee E55 Organization

E55.01 PAT Systems Management E55.02 PAT Systems Implementation &

Practice E55.90 Executive Subcommittee E55.91 Terminology

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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

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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