Standards for Pharmaceutical Applications of PAT

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Standards for Pharmaceutical Applications of PAT

• Don Marlowe
• FDA Standards Coordinator
• Office of the Commissioner

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Outline

• Why use consensus standards
• What is ASTM
• History of Committee
• Committee Organization

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Why use the consensus standards process for PAT

• Involvement of all interested parties
• Balanced discussion
• Due process
• NTTAA

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ASTM

• ANSI accredited standards development
  organization
• gt100 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 _at_
  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

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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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E55 Overview of Activity
Describe the overall work plan and outcomes
Operations and Maintenance
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Access Information for ASTM E55

• Pat Picariello
• E-mail ppicarie_at_astm.org
• Web site - www.astm.org