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Commissioning and Qualification
Presented by Marc Fini
21 May, 2013
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Slide 2 © PharmOut 2013
Commissioning and Qualification
Performing qualification to avoid non compliance will lead you to failure.
Perform qualification to minimise the impact of risks on:
Product safety
Patient safety
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Slide 3 © PharmOut 2013
Commissioning and Qualification
What is commissioning?
Engineering activity
Planned, documented and managed process
Start up and handover of ‘systems’
Safety and functionality
DQ and stakeholder expectations
Find and fix problems
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Slide 4 © PharmOut 2013
Commissioning and Qualification
What is qualification?
Science based
IQ, OQ, PQ
Documented verification that all aspects of a ‘system’ that can affect product quality, perform as intended
Confirm the critical functionality of direct impact systems
Targeted approach
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Slide 5 © PharmOut 2013
Commissioning and Qualification
• Approved specifications, construction, materials and installation
IQ
• Operation as intended through all anticipated ranges
OQ
• Perform as intended, meeting pre-determines acceptance criteria
PQ
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Slide 6 © PharmOut 2013
Commissioning and Qualification
Focus qualification on what’s important.
Quality by Design (QbD)
Manufacturing processes and formulation
Product quality
Process control strategies
Risk based regulatory scrutiny
Patient safety
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Slide 7 © PharmOut 2013
Commissioning and Qualification
Risk based approach
• Design strategy
• Commissioning and Qualification strategy
• Automation and Maintenance strategies
Tools
• Commissioning and Qualification strategy
• Impact assessments
• Technology transfer
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Slide 8 © PharmOut 2013
Commissioning and Qualification
Maintaining the validated state requires:
Operational analyses
Change management
Feedback loop
Process performance
reviews
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Slide 9 © PharmOut 2013
Commissioning and Qualification
The basis for qualification:
User Requirement Specification
System impact assessments
Heavier initial workload
Focussed approach
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Slide 10 © PharmOut 2013
Impact Assessment
Components
Syste
ms
Critical Non-Critical
Direct Impact
Indirect / No Impact
Not P
ossib
le
Commissioning and
Qualification Commissioning only
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Slide 11 © PharmOut 2013
Commissioning and Qualification
Costs
• Technology transfer
• URS
• Risk assessments
• Impact assessments
• DQ
Benefits
• Better engineered system
• Streamlined qualification
• Priorities
• Targeted approach
• Compliance
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Slide 12 © PharmOut 2013
Commissioning and Qualification
There are components of commissioning and qualification that require careful management.
The methodology for change and deviation management needs to be determined before validation begins.
The commissioning and qualification effort needs:
• Engineering evaluation
• QA evaluation
• Project structure and strategies
• Tracking of implementation
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Slide 13 © PharmOut 2013