1. ACPS Manufacturing Subcommittee July 20041 Standards for Pharmaceutical Applications of PAT Don Marlowe FDA Standards Coordinator Office of the Commissioner

2. ACPS Manufacturing Subcommittee July 20042 Outline Why use consensus standards What is ASTM History of Committee Committee Organization

3. ACPS Manufacturing Subcommittee July 20043 Why use the consensus standards process for PAT Involvement of all interested parties Balanced discussion Due process NTTAA

4. ACPS Manufacturing Subcommittee July 20044 ASTM ANSI accredited standards development organization >100 years of experience in standards development Recognized developer of international standards Offices in W. Conshohocken, PA

5. ACPS Manufacturing Subcommittee July 20045 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 – 1 st meeting of ASTM E55 Standard Terminology E 2363 published May 2004 – 2 nd Meeting of ASTM E55

6. ACPS Manufacturing Subcommittee July 20046 Committee E55 Organization E55.01 PAT Systems Management E55.02 PAT Systems Implementation & Practice E55.90 Executive Subcommittee E55.91 Terminology

7. ACPS Manufacturing Subcommittee July 20047 E55 Overview of Activity n E55.02 E55.01 Describe the overall work plan and outcomes WI Equipment Environment Raw Materials People Analytical Equip& Cntrls Transport & Storage Process Design First step of primary to final packaging Product Systems Infrastructure Operations and Maintenance

8. ACPS Manufacturing Subcommittee July 20048 Access Information for ASTM E55 Pat Picariello E-mail ppicarie@astm.orgppicarie@astm.org Web site - www.astm.org