Precision and accuracy are two critical words (but with different meanings*) in pharmaceutical, food processing and other industries that come under continuous scrutiny by the FDA, the Code of Federal Regulations Title 21 and other standards. In brief IQ, OQ and PQ mean Installation Qualification, Operational Qualification and Performance (or Process) Qualification. The letter V for verification can be used in place Q.
But we promised a PDQ explanation, so let’s take a quick look at IQ, OQ and PQ.
The Purpose of IQ, OQ and PQ
A purpose of IQ, OQ and PQ is ensuring that sensitive laboratory and processing equipment meet strict standards as those mentioned above. An example of such equipment is an HPLC system, including its pumps. These systems must precisely and accurately analyze pharmaceutical compounds as they proceed from R&D into manufacturing. More simply stated IQ, OQ and PQ mean that equipment performs “as advertised.”
Installation Qualification Described
As described in an FDA Group blog post “Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results.”
But this qualification is not a one-time step for brand new equipment. It also applies to used equipment that you purchase for your site. Moreover, IQ can also come into play if your equipment is moved to another location in your facility.
Successful passing the IQ hurdle is aided by adhering to manufacturers’ guidelines during the installation procedures. These can be quite extensive and include issues such as floor space, adequate power and the operating environment.
Operational Qualification Defined
Once the equipment is installed and passes the IQ hurdle it must be qualified to operate “as advertised” under actual operating conditions expected by the user and within specifications provided by the manufacturer.
Think of OQ as a test run.
As described by our above cited source, “In general, OQ serves as a detailed review of hardware or software startup, operation, maintenance, cleaning and safety procedures (if and where they’re applicable). Every unit of hardware and software must be shown to be operating within the specified limits.”
OQ (as well as IQ and PQ) exercises can be performed by properly trained onsite personnel or by engaging qualified outside service providers.
As an example, OQ tests for an HPLC system include checking the accuracy and precision of the pump flow. You’ll find a brief description of this exercise at the end of this post.
Performance Qualification Described
The PQ hurdle must be successfully scaled before starting commercial production.
Performance qualification (or Validation) means that your equipment, under actual operating conditions, meets all predetermined requirements.
If several pieces of equipment are involved, all must work together “as advertised” before a PQ certificate is issued.
A detailed look at process validation is found in this FDA publication. And please keep in mind that PQ as with OQ is not a one-time exercise but part of an ongoing program to help assure that your company conforms to good manufacturing practices.
An OQ Example: Validating High Performance Liquid Chromatography Systems
Researchers know a critical if not the most critical aspect of an HPLC system is providing uniform and reproducible column retention times for analytes. The retention time is dependent upon the pump flow rate. Therefore, the OQ test protocol includes testing the pump flow for accuracy and precision.
After initial operational qualification (OQ), periodic calibration checks of HPLC pump systems must be undertaken to confirm OQ and to identify and correct flow rate variances that may develop, for example, from factors such as worn pump seals or sediments that interfere with flow rates.
These calibration tests are performed by checking flow rates while pumping solvent through the HPLC system.
Testing the flow rate manually is a long and tedious process as described in our post on flow meter accuracy.
Instead, on-site personnel or those engaged from outside service providers can couple a FlowCal 5000 flowmeter to collect solvent exiting from the HPLC system.
Then the FlowCal 5000 takes over and makes repeated flow rate measurements that are sent via an RS232 interface to a printer or computer for record keeping. The researcher is free to do other work in the lab.
The benefits of the FlowCal 5000 are expressed in several user testimonials available on our website.
For additional information on IQ, OQ and PQ issues, or for further details on the FlowCal 5000 liquid flow meter please contact the scientists at Tovatech.
*While precision and accuracy are sometimes (and erroneously) considered the same, such is not so. Precise means that results are consistent. However they may be consistently wrong, and therefore not accurate.