Tuesday, February 17, 2009

ASTM E 2500 – 07, What is it? - salient features

•“A risk-based and science-based approach to the specification, design, and verification of manufacturing systems and equipment that have the potential to affect product quality and patient safety.”
•“The overall objective is to provide manufacturing capability to support defined and controlled processes that can consistently produce product meeting defined quality requirements.”
this is Approved June 1, 2007
–An ASTM Standard
–A voluntary consensus standard
–It has legal relevance
•The term “Validation” appears only 1 time
–“quality”, (not Quality Assurance or Quality Unit) appears 44 times
–“expert” appears 21 times
–“critical” appears 20 times
•The terminology implies knowledge of what’s important to your system

What ASTM E 2500 Applies To
Pharmaceutical and biopharmaceutical manufacturing systems:
  • Facility equipment
  • Process equipment
  • Supporting utilities
  • Process monitoring and control systems
  • Automation Systems that have the potential to affect product quality and patient safety
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  • Review of how these ASTM and ICH approaches can simplify the qualification process.
  • Documentation of design.
  • Risk mitigation by design review and operational practices.
  • The role of subject matter experts.
  • Use of risk management techniques to drive the extent of systems verification and level of documentation detail.
  • Acceptability of well-managed changes to systems.

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