Definition: IQ/OQ/PQ

IQ/OQ/PQ refers to the 3 activities that must be performed on equipment and machines as part of the validation of manufacturing processes: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Installation Qualification (IQ):

Performed to ensure that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment (usually according to the installation manual) are suitably considered. 

When performing IQ, a few key points to keep in mind include:

  • Equipment design features (i.e. materials of construction cleanability, etc.)
  • Installation conditions (wiring, utilities, functionality, etc.)
  • Calibration, preventative maintenance, cleaning schedules
  • Safety features
  • Supplier documentation, prints, drawings and manuals
  • Software documentation
  • Spare parts list
  • Environmental conditions (such as clean room requirements, temperature, humidity)

Operational qualification (OQ):

Performed to ensure that process control limits and action levels which result in the product meets all predetermined requirements.

When performing OQ, a few key considerations include:

  • Process control limits (time, temperature, pressure, line speed, setup conditions, etc.)
  • Software parameters
  • Raw material specifications
  • Process operating procedures
  • Material handling requirements
  • Process change control
  • Training
  • Short term stability and capability of the process, (latitude studies or control charts)
  • Potential failure modes, action levels and worst-case conditions (Failure Mode and Effects Analysis, Fault Tree Analysis)
  • Use of statistically-valid techniques such as screening experiments to establish key process parameters and statistically-designed experiments to optimise the manufacturing process

Performance qualification (PQ):

Performed to ensure that all processes, under anticipated conditions, consistently produce a product which meets all predetermined requirements.

When performing PQ, a few key items to ensure include:

  • Actual product and process parameters and procedures established in OQ
  • Acceptability of the product
  • Assurance of process capability as established in OQ
  • Process repeatability, long term process stability

Conducting PQ would require you to run the relevant processes a few times to collect the relevant objective evidence.

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