IQ OQ PQ. Installation, Operational, Performance Qualification.
IQ – Installation QualificationThe purpose of the installation qualification is to demonstrate that all the critical components of process equipment and support installations have been installed appropriately and are installed to the respective manufacturer’s or supplier’s requirements. The installation qualification requirements will normally be outlined in an IQ protocol, which will detail the testing and checks to be performed and give an indication of the expected results.
Upon completion of the IQ protocol, the results obtained will be compared to the expected results in order to determine if the equipment and associated support installations have been installed appropriately to requirements.
OQ – Operational QualificationThe objective of the operational qualification is to define the specifications and controls for the process which will result in acceptable output. The operational qualification confirms that the process will operate within the defined specifications and control limits. The operational qualification needs to take account of the product or process requirements, for example a manufacturer may guarantee equipment operation across a broad spectrum of operation, whereas only a narrow spectrum may be required in actual operation. In such a scenario, only the narrow spectrum of operation needs to be qualified.
Here again, an OQ test protocol will be defined and approved in advance of OQ performance. The OQ protocol will define the testing to be performed and the expected results. Upon completion of the OQ protocol an OQ report will be documented, detailing the actual results versus the expected results.
PQ – Performance QualificationThe objective of the performance qualification is to demonstrate that the process as operated under normal expected conditions will produce acceptable output. It is normal to process a number of batches or product lots as part of the PQ. Usual practice was to complete 3 separate lots and many business still apply this “3 lot” rule, however, the decision regarding the quantity and size of batches used for a PQ should be based on a risk assessment, the greater the potential risk then more lots or larger lots may be appropriate.
Again, a PQ protocol will be completed in advance of performance, which will detail the expected results. Upon completion of the PQ, the results obtained will be documented and compared to expected outcomes.
The IQ OQ PQ qualification requirements will usually be outlined in a Master Validation Plan. Only upon successful completion of all three qualifications can a process be considered fully qualified or validated.
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