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TO COMMISSIONING &
QUALIFICATION
A methodology to qualify only those design aspects that have been classified as critical-to-product-quality,
based on SMEs’ assessment.
All other design aspects are tested under commissioning (engineering testing).
Risk-Based methodology is based on 10 principles:
1. Focus on that which affects product quality
2. Process User Requirements key to acceptability
3. Risk assessments and process knowledge used to identify critical elements
4. Only critical features/functions to be qualified
5. All activities must contribute value
6. Risk-based asset delivery – not “cookbook” requirements
7. Value-added documents based on technical merit
8. Use of supplier documentation
9. Test planning (and “leverage” testing – redundant testing only when necessary)
10. Foster innovation – not all change is bad
ISPE White Paper “Risk Based Qualification for the 21st Century” March 2005
• (Product) User Requirements not Formally Documented • Process Requirements Documented, Approved
• Protocols Developed from “Templates” • Risk Assessments Determine Critical Aspects of Design
• IQ/OQ Protocols QA “Preapproved” • Engineering Testing (“Commissioning”) Verification
• Commissioning not Leveraged • All Documents with Technical Merit Used as Evidence of Fitness for
Use
• Engineering and “Validation” Personnel Often Distinct
• Emphasis on Meeting Process Requirements
• Emphasis on Documents
Focus on impact to product quality & patient safety Number of Tests at Various Project Stages
Note:- The FDA Process Validation Guide refers to this ASTM standard as an
acceptable approach for qualification.
ASTM E2500 – 13
Structured Approach
Clear
definitions of
Risk tolerance each class
based on RPN
& company’s
internal policies
Full Traceability
Transition Management
Flexibility