Definition of the term („What is a Performance Qualification?“)
The Performance Qualification (PQ) is an element of the qualification for machines and devices especially applied in GMP-compliant industrial manufacturing or officially controlled products (such as medicinal substances) as part of the quality assurance. Furthermore, it serves to ensure sustained quality with regard to the measurement results of e.g. analytical instruments. If necessary, it is adjusted to the standard operating procedures.
With regard to the analytical devices in the pharmaceutical quality control, the PQ is equivalent to the OQ (Operation Qualification). Typically, the aspects of the Operation Qualifications (OP) are chosen to be milder than those of the Installation Qualification (IQ). This way, the continuous operation of the devices with constant adjustment can be ensured. Moreover, all devices which operate properly under normal conditions are also considered.
The following sets of rules act as characteristics for the PQ:
- EU-GMP guideline, chapter 3 and Annex 15 and OMWHV § 5
- ISO 17025
- For system-specific, detailed requirements: EDQM Quality Management Guidelines
- General requirements for pharmacopoeias
- USP General Chapter <1058> “Analytical Instrument Qualification”
- Norms (EN, ISO, DIN)