IQ (Installation Qualification)

The IQ is the first of the three GMP regulatory qualifications. It demonstrates in a documented way that automated equipment is installed in accordance with specifications, under conditions allowing GMP operation. We execute it through a signed protocol that verifies conformity to as-built P&ID and electrical drawings, component serial numbers and firmware, material certificates for product-contact parts, initial calibrations of critical instruments, connected utilities, on-site documentation, plus the creation of user accounts and the allocation of rights according to the URS-defined matrix. Any deviation is tracked in the site QMS and the IQ is closed only when all gaps are resolved or justified by quality.