What are IQ, OQ and PQs?

What are IQ, OQ and PQs?

After the installation of a new water system there are qualification periods to ensure that the system is operating as defined by the user requirement specification (URS). There is also a requirement to ensure that the system is producing water compliant with the specifications outlined in the pharmacopoeial monograph. Installation Qualification (IQ) is defined by regulatory bodies as establishing confidence that a water system meets the original design specifications set out by the manufacturer. The next phase is Operational Qualification (OQ), this phase allows us to determine if the system is capable of continuously providing water of the quality defined in the User Requirement Specification (URS) in accordance with the relevant regulatory requirements. The final stage is Performance Qualification (PQ), this is not dissimilar from the OQ stage, but is conducted over a longer period of time. A PQ assesses the capabilities of the system to produce compliant water reliably over the course of a year of normal operation.