Standards for Pharmaceutical Applications of PAT

1. Standards for Pharmaceutical Applications of PAT Don Marlowe FDA Standards Coordinator Office of the Commissioner ACPS Manufacturing Subcommittee July 2004

2. Outline • Why use consensus standards • What is ASTM • History of Committee • Committee Organization ACPS Manufacturing Subcommittee July 2004

3. Why use the consensus standards process for PAT • Involvement of all interested parties • Balanced discussion • Due process • NTTAA ACPS Manufacturing Subcommittee July 2004

4. ASTM • ANSI accredited standards development organization • >100 years of experience in standards development • Recognized developer of international standards • Offices in W. Conshohocken, PA ACPS Manufacturing Subcommittee July 2004

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 2004 – 1st meeting of ASTM E55 • Standard Terminology E 2363 published • May 2004 – 2nd Meeting of ASTM E55 ACPS Manufacturing Subcommittee July 2004

6. Committee E55 Organization • E55.01 PAT Systems Management • E55.02 PAT Systems Implementation & Practice • E55.90 Executive Subcommittee • E55.91 Terminology ACPS Manufacturing Subcommittee July 2004

7. E55.01 Raw Materials n Process Design WI Equipment WI Environment Product First step of primary to final packaging E55.02 People Analytical Equip& Cntrls WI WI Transport & Storage Systems Infrastructure E55 Overview of Activity Describe the overall work plan and outcomes Operations and Maintenance ACPS Manufacturing Subcommittee July 2004

8. Access Information for ASTM E55 • Pat Picariello • E-mail ppicarie@astm.org • Web site - www.astm.org ACPS Manufacturing Subcommittee July 2004