Upload
augustine-thompson
View
212
Download
0
Embed Size (px)
Citation preview
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
2
Outline
Why use consensus standards What is ASTM History of Committee Committee Organization Committee Officers Sub-committee Officers
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
ASTM
ANSI accredited standards development organization
>100 years of experience in standards development
Recognized developer of international standards
Offices in W. Conshohocken, PA
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 – 1st meeting of ASTM E55
Next meeting – 18-20 May, Salt Lake City
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
Committee E55 Organization
E55.01 PAT Systems Management E55.02 PAT Systems Implementation &
Practice E55.90 Executive Subcommittee E55.91 Terminology
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
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