IQ/OQ/PQ qualification of a GMP instrument: a practical guide to DQ, IQ, OQ, PQ
How to qualify a GMP instrument or piece of equipment: DQ, IQ, OQ, PQ protocols according to GAMP5 and Annex 15, who performs it and what is needed for the audit.
Resource cluster
GMP qualification guides
IQ/OQ/PQ, smoke study, thermal requalification and change control according to GAMP5.
Pillar 7 min Annex 15 requirements for the qualification of equipment
What Annex 15 of the EU GMP requires for the qualification of equipment, plants and utilities: VMP, URS, phased DQ/IQ/OQ/PQ approach, requalification and change control.
7 min Who can perform the qualification of a GMP instrument (and how much it costs)
Who can perform the IQ/OQ/PQ qualification of instruments and equipment in a GMP context, what to ask a qualification service provider in Italy and what the cost depends on.
6 min The difference between calibration and qualification of an instrument
Calibration and qualification are not synonyms: the first guarantees the accuracy of the measurement, the second demonstrates that the instrument is fit for use. How they integrate in GMP.
6 min Thermal requalification of chambers, autoclaves and temperature-controlled environments
What thermal requalification (thermal mapping) is, when it must be redone and how it is performed on climatic chambers, autoclaves and GMP warehouses: probes, distribution and heat penetration.
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