Académique Documents
Professionnel Documents
Culture Documents
Existing Paradigm
Science and Risk-Based Approach to The V model with full protocol driven documentation
Qualification of Utilities Comprehensive verification of installation and
operation against detailed specifications
Focus on all aspects not just quality outcome aspects
QA oversight and sign off of all steps
IQ and OQ are part of qualification, not seen as pre-
requisites
SeerPharma Pty Ltd
This training program is copyright to SeerPharma Pty Ltd and may not be modified, reproduced,
Repeat of vendor commissioning work
sold, loaned, hired or traded in any form without the express written permission of SeerPharma.
Regulatory inspection of evidence based on detailed
documentation, includes GEP commissioning
National Regulatory Conference 2008 1 National Regulatory Conference 2008 2
Traditional / Current
Typical Qualification Documentation V Model Approach to Validation
The evaluation of the risk to ISPE White Paper - Risk Based Qualification
quality should ultimately link - March 2005
back to the protection of the
patient;
Note: Severity is sometimes referred to as Consequences
Prepare a final Qualification Report (QR) after PT completion
Process SME Final Package
Validation QA of Reports
Auditable by regulators ?
Risk Assessment
National Regulatory Conference 2008 15 National Regulatory Conference 2008 16