What Is IQ OQ P-WPS Office

What is IQ OQ PQ?
For industries involved in pharmaceutical and health care products, or even laboratories, product quality
is paramount and minute inconsistencies can have disastrous results. Installation Qualification (IQ),
Operational Qualification (OQ) and Performance Qualification (PQ) are an essential part ofquality
assurance through equipment validation.
What Do IQ, OQ and PQ Mean?
IQ OQ PQ protocols are ways of establishing that the equipment which is being used or installed will
offer a high degree of quality assurance, so that manufacturing processes will consistently produce
products that meet predetermined quality requirements. To understand these terms better, let’s look at
each of them one by one:
Installation Qualification (IQ)
Any new equipment is first validated to check if it is capable of producing the desired results through
Design Qualification (DQ), but its performance in a real-world scenario depends on the installation
procedure that is followed. Installation Qualification (IQ) verifies that the instrument or equipment being
qualified, as well as its sub-systems and any ancillary systems, have been delivered, installed and
configured in accordance with the manufacturer’s specifications or installation checklist.
In addition to this, any cGMP requirements that pertain to the IQ and the approach used for IQ is
thoroughly-documented in the Validation Master Plan (VMP).
For successful qualification, the installation must meet manufacturer requirements, like:
Installation location and floor spacePower, gas supply and other energy sourcesEnvironmental and
operating conditionsUnpacking instruments and checking for damageCross-checking contents against
the packing listDocumentation of computer-controlled instrumentationChecking software-installation
and basic accessibilityInstallation ancillary instruments and optionsVerifying connections and
communication with peripheral unitsRecording firmware versions and serial numbersTagging
instruments with IQ stickersRecording calibration and validation dates of equipment used for
IQGathering all manuals and certificates of conformity
Operational Qualification (OQ)
Once each protocol of the IQ phase has been met, Operational qualification (OQ) is performed to check
that the equipment’s performance is consistent with the user requirement specification, within the
manufacturer-specified operating ranges. During the OQ phase, all the items in the test plan are tested
individually and their performance documented. This is a prerequisite for technical acceptance of the
equipment and the facility, so it can only be performed once the IQ has been successful.
Apart from qualification after the initial installation, requalification also needs to be carried out after any
major maintenance work or modifications have been made to equipment, or as part of a regular quality
assurance schedule.
The main purpose of OQ is to identify and inspect features of the equipment that can influence final
product quality, like:
Display units and signaling LEDsTemperature controls and fluctuationsOverheating and low-temperature
protection systems and alarmsPressure/Vacuum controlling systemsCO2 controlling systemsHumidity
measuring and controlling systemsFan and fan-speed controllersServo motors and air flap
controllersCard readers and access controllersTemperature distribution in accordance with DIN 12880:
2007-05
Performance Qualification (PQ)
PQ is the final step in qualification processes for equipment, and this step involves verifying and
documenting that the equipment is working reproducibly within a specified working range. Rather than
testing each instrument individually, they are all tested together as part of a partial or overall process.
Before the qualification begins, a detailed test plan is created, based on the process description.
Process Performance Qualification (PPQ) protocol is a vital part of process validation and qualification,
which is used to ensure ongoing product quality by documenting performance over a period of time for a
certain process.
FDA guidelines recommend including the following criteria as part of PQ and PPQ protocols:
Manufacturing conditions like equipment limits, operating parameters and component inputsA list of the
data that should be recorded or analyzed during tests, calibration and validationTests that need to be
performed to ensure consistent quality at various steps of productionA sampling plan which outlines the
sampling methods used during and in between production batchesAnalysis methodology for making
data, scientific and risk-oriented decisions based on statistical dataDefining variability limits and
contingency plans for handling non-conformanceApproval of the PPQ protocol by relevant departments
Qualification of Equipment
Equipment qualification through DQ IQ OQ PQ practices is a part of Good Manufacturing Practice (GMP),

through which manufacturers and laboratories can ensure that their equipment delivers consistent
quality. It reduces the margin for errors, so the product quality can be maintained within industry
standards or regulatory authority requirements. When qualification of equipment is not needed very
frequently, performing it in-house might not be feasible, so smaller laboratories might benefit from
scheduling external equipment validation services on a basis instead.

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What is IQ OQ PQ?

What Do IQ, OQ and PQ Mean?

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Equipment qualification through DQ IQ OQ PQ practices is a part of Good Manufacturing Practice (GMP),

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