What are IQ OQ PQ and why are they critical to the pharmaceutical and medical device manufacturing industry?

IQ OQ PQ or or Installation Qualification, Operational Qualification and Performance Qualification

What are IQ OQ PQ in Pharma?

IQ OQ PQ or Installation Qualification, Operational Qualification and Performance Qualification are 3 independent and documented procedures used together to check and test that a mechanical, piping or software system is;

  • installed correctly
  • meets its design requirements and specifications
  • operates the way in which it was designed under load

It’s an exhaustive, time consuming but necessary process.

If you work in pharmaceutical or medical device manufacturing, you’ve probably heard the terms IQ OQ PQ especially when people talk about installation and commissioning of a new manufacturing plant or its equipment.

But unless you’re directly involved with these procedures, you might not have a detailed understanding of what they mean.

Want a more detailed explanation of each? Here goes…

(By the way, if you need to learn how to perform an IQ IQ PQ, check out our program on Commissioning & Qualification (IQ OQ PQ) and Retrain for Starter Validation Roles.)

What is IQ or Installation Qualification?

Installation Qualification is a documented process that verifies that all aspects of facility, utilities and equipment that affect product quality adhere to the approved design specifications, and that the piece of equipment or instrument has been;

  • Properly delivered
  • Correctly installed
  • Configured according to standards set by the manufacturer or by an approved installation checklist

Installation Qualification is the first step in the qualification of new equipment.

Once equipment is ordered and has arrived on-site, it is the job of the Commissioning and Qualification (C&Q) engineers to verify that the technical specifications of the equipment match the technical requirements as were determined in the facility design element of the qualification process

The C&Q engineers compare the Manufacturers Technical Specification Data Sheet to the design and operational requirement determined during facility design. Data which might be recorded at this phase of qualification include:

  • Materials
  • Dimensions
  • Minimum, Maximum and Working Temperatures
  • Minimum, Maximum and Working Pressures
  • Surface Roughness
  • Minimum and Maximum Flow Rate
  • Volume
  • Torque
  • Watts, Voltage and Current

Other checks and procedures that are carried out include;

  • Cross-checking of contents against the packing list and checking for damage
  • Checking the correct piece of equipment is installed in its proper location
  • Verifying (wiring or piping) connections with other units or equipment
  • Checking the installation of secondary instruments and ancillary equipment
  • Checking for proper energy or utilities supply
  • Confirming that the environmental and operating conditions are within the manufacturer’s guidelines
  • Verifying software installation
  • Recording firmware versions and serial numbers
  • Recording calibration and validation dates of equipment used for the qualification
  • Gathering all documentation, manuals, calibration certificates and certificates of conformity

In a practical sense, Installation Qualification is the oversight and verification of every physical aspect of the equipment (materials, dimensions, pressure ratings, etc.), software design specification (software, accessibility, processor speed, etc.) and instruments (operational parameters, accuracy, voltage, etc.).

Check out 4 professional IQ, OQ PQ Templates you can use right now to help with your qualification and validation projects.

These testing templates are collated in a document called a Validation Protocol which is a written plan stating how validation will be conducted. It details factors like:

  • Test scripts and methods – telling you the steps involved in conducting a test
  • Test parameters and acceptance criteria – defining acceptable test results
  • Test checksheets – documenting and recording the test results
  • Product characteristics – showing what your system is looking to achieve/produce
  • Production equipment – detailing the equipment necessary
  • Final approval – documenting that the validation process has been successfully carried out

What is OQ or Operational Qualification?

Operational Qualification is the testing of each individual component/feature/physical specification of the equipment and is the next step in equipment qualification.

Once the equipment has passed the IQ phase the operational requirements, as well as the operational consistency of the equipment, must be put to the test.

To carry this out, C&Q engineers must work with maintenance personnel, process & mechanical engineers and operations to carry out various tests on the equipment. Features of the equipment which might be tested at this phase of qualification include:

  • Temperature Control Systems
  • Overheating/Low-Temp Alarms
  • Pressure Control Systems
  • Fan/Motor Speed/RPM
  • Display Units/Human-Machine Interface Units (HMI’s)
  • Operational Signals
  • Servo Motors Accuracy
  • Pressure Switches
  • Level Switches

Tests of these features may involve simple tests such as sending power to the unit and opening/closing different ports and valves to ensure signals, switches or HMI’s to ensure that the components are in working order.

Other more complicated testing may need to be carried out such as the following:

  • Pressure Test
  • Flow Test
  • Testing of Equipment Interlocks
  • Speed Test

It is important to highlight that during this phase of qualification, each test is carried out individually. For example, if a shell & tube heat exchanger was being pressure tested for operational qualification, it is essential that the shell of the heat exchanger be tested at a different time to when the tubes of the heat exchanger be tested.

Essentially, Operational Qualification is the testing of each individual component/feature/physical specification of the equipment.

What is PQ or Performance Qualification?

Performance Qualification is the final step in equipment qualification. It is much like Operational Qualification, as it tests the operational requirements of the equipment, but in this case, the equipment will contain a load or process medium.

In other words, it is the testing of equipment while being subject to “real-world” conditions – conditions which the equipment would be subject to during batch production.

This phase is hugely important as it combines the workings, forces and energy of the individual components of the equipment into one harmonious system. By doing so, faults such as the examples below (as well as many more) can be discovered in this phase of qualification:

  • Excessive Vibration/Noise – This may be caused by a combination of 2 or more individual vibrating components.
  • Excessive Heat – This may be caused by a build-up of heat due to a driving belt.
  • Process Media Backflow – This may be caused by incorrect sizing of pipework (a factor which is only highlighted in this case).
  • Pressure Differentials – This may be caused by the use of a valve (toggle open/closed) or other equipment, as well as Process Media Backflow, as mentioned above.
  • Combination of Individual Faults – Problems in the system can also arise due to a combination of these faults.

The working environment around the system can also be affected by the equipment in use. Excessive heat, for example, can cause a dramatic increase in room temperature depending on what process is being carried out.

The spike in room temperature may be uncomfortable for personnel to work in and could possibly be unsafe if personnel are exposed to the high temperatures for an extended period of time. Equally, excessive vibration/noise can not only cause damage to the equipment, but could also be a safety hazard to personnel in the area.

In any case, steps must be taken to deal with such problems, whether it be increased air conditioning to combat excessive heat or fitting noise dampening features to the system to reduce vibration/noise, or by simply cordoning off the area while the equipment is in use.