When we talk about IQ OQ PQ we mean the process of qualifying an automated machine: how it is composed, its operational processes and the performance achieved. The qualification of the equipment is part of the pharmaceutical validation process, which is the responsibility of the user of the equipment and aims to prove that the production, manufacturing, packaging and distribution process of the product manufactured by the equipment ensures the protection of the final patient.
Read also the article “The difference between validation and testing”
IQ = Installation Qualification
This is the validation that verifies and tests the correct assembly of the machine, the presence and positioning of the components.
OQ = Operational Qualification
Checks all the operations carried out by the machine.
PQ = Performance Qualification
Verifies the performance of the machine in accordance with contractual requirements.
In addition to these, the DQ (Design Qualification) must also be considered, i.e. the documentation that certifies the machine’s design processes. Read more about Design Qualification.
The Validation Protocol is drawn up according to the GMP (Good Manufacturing Practice) and GAMP 5 (Good Automated Manufacturing Practice) guidelines created and used for the pharmaceutical sector.