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
|