ViP Definition
"Installation Qualification is the provision of documented evidence to demonstrate that all key aspects of an installation adhere to approved design intentions, that all applicable CGXP, GEP, user and process requirements have been addressed, and that manufacturers' recommendations have been suitably considered."
With an approved Compliance Review (or DQ Report), and with development of the design under strict change control, IQ should simply be a case of verifying that the static attributes of an installation are what you asked for, and what you were told you would get. If there are any CGXP non-compliances at this stage, either the specification was wrong, it was not adhered to, or it left scope for incorrect interpretation.
We strongly recommend that qualification be limited to the elements of an installation impacting on product quality and regulatory compliance, and that, on completion, these elements are routinely verified as part of the planned preventive maintenance programme, rather than a formal requalification.
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