New ASTM Commissioning

1
New ASTM Commissioning Qualification Standard

• ISPE BioPharma 07
• New England Chapter
• January 18, 2007
• David E. Petko, P.E.

2
Status

• May 2006 ASTM Ballot
• ISPE Annual Meeting
• November 2006 ASTM Ballot Any negative vote
  shall be given consideration by the subcommittee
  in accordance with regulations.

3
Question

• Why change our work cultures, regulatory
  framework to move from the traditional
  qualification approach to a value added model?

4
Scope

• The proposed ASTM standard provides a science and
  risk based approach to assure that GMP
  equipment systems are fit for use, perform
  satisfactorily, and may be used in the
  manufacturing, processing, packaging, and holding
  of a drug
• ASTM Standard for Specification, Design
  Verification of Pharmaceutical
  Biopharmaceutical Manufacturing Systems
  Equipment

5

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Engineering Change Management
QA Change Control
Design Development

• Current CQ Guidance

Enhanced Design Review
ProcessValidation
Commissioning
PQ
IQ OQ
Engineering Change Management
QA Change Control

• New risk-based approach

Design Development
Verification Testing
ProcessValidation
PT
Design Review
Performance Testing
7
Old vs. New Way

• Old Qualification consists of a series of IQ,
  OQ, and PQ Protocols
• New Verification consists of confirming the
  commissioning activities have been completed, GMP
  readiness activities completed, followed by
  integrated performance testing

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Risk-based approach
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Thank You!