ASTM E2500


The differences betwee the ASTM guide and the ISPE Baseline guide are shown in the table below.

ISPE Baseline guide ASTM guide
  • Design inputs
  • Impact assessment
  • Design Qualification
  • Commissioning
  • Multiple trial runs to get things right
  • IQ, OQ, PQ and acceptance criteria
  • GEP Scope and QA Scope overlapped
  • Focused on Documentation Deliverables
  • Rigid Change Management

  • Design inputs
  • Design Review
  • Risk Mitigation
  • Critical Control Parameters define Acceptance Criteria
  • Verification Testing
  • Performance Testing
  • GEP Scope and QA Scope have clear boundary
  • Process, Product Quality and Patient Safety
  • Quality by Design, Design Space and Continuous Improvement