Presentation at GSK Barnard Castle site. What stage in the validation lifecycle is the most critical?
by
Roberto Sanchez

Validation Lifecycle: Is a principle that ensures that quality is built into the equipment/facilities and standards are established for the processes. Starts with the equipment/facility validation and ends when it is retired.

Stages to be evaluated

• IQ
• OQ
• PQ

Points to be cosidered in the stage

• Capability of error detection
• Capability to solve a problem
• Impact in the business
• Impact in customer's health
• Impact of a failure in next validation stages

Risk ANALYSIS for validation stageS

• Capability of error detection (CE). 0 point high level of detection and 1 point low level of detection.
• Capability to solve a problem (CS). 0 point high capability and 1 point low capability of detection.

RISK ANALYSIS FOR VALIDATION STAGES

• Impact in the business (IB). 1 point high impact and 0 point low impact.
• Impact in customer's health (ICH). 1 point high impact and 0 point low impact.
• Impact of a failure in next validation stages (IVS). 1 point high impact and 0 point low impact.

STAGES evaluation

• POINTS:CE CS IB ICH IVS
• IQ: 0 0 0 0 1
• OQ: 0 0 1 1 1
• PQ: 1 1 1 1 0

CONCLUSIONS:
After considering different aspects, the most critical stage in the validation lifecycle is PQ.

Thank you very much for your attention