Responsibility of IQ OQ PQ analyst?

Responsibility of IQ OQ PQ analyst?

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 of quality 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 space

·         Power, gas supply and other energy sources

·         Environmental and operating conditions

·         Unpacking instruments and checking for damage

·         Cross-checking contents against the packing list

·         Documentation of computer-controlled instrumentation

·         Checking software-installation and basic accessibility

·         Installation ancillary instruments and options

·         Verifying connections and communication with peripheral units

·         Recording firmware versions and serial numbers

·         Tagging instruments with IQ stickers

·         Recording calibration and validation dates of equipment used for IQ

·         Gathering 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 LEDs

·         Temperature controls and fluctuations

·         Overheating and low-temperature protection systems and alarms

·         Pressure/Vacuum controlling systems

·         CO2 controlling systems

·         Humidity measuring and controlling systems

·         Fan and fan-speed controllers

·         Servo motors and air flap controllers

·         Card readers and access controllers

·         Temperature 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 inputs

·         A list of the data that should be recorded or analyzed during tests, calibration and validation

·         Tests that need to be performed to ensure consistent quality at various steps of production

·         A sampling plan which outlines the sampling methods used during and in between production batches

·         Analysis methodology for making data, scientific and risk-oriented decisions based on statistical data

·         Defining variability limits and contingency plans for handling non-conformance

·         Approval 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 regular basis instead.