PQ helps to keep the laboratory productivity high. The PQ process verifies fitness for intended use (for a given analytical method with fixed conditions of use).
USP <1058> on analytical instrument qualification requires that PQ is now more linked to the original URS.
SSTs alone are not sufficient any more so that PQ is not a single activity.
For instruments and software PQ includes
- Monitoring instrument parameters to schedule timely preventive maintenance before an instrument error occurs
- Test plans with acceptance criteria related to the URS
- Preventive maintenance plans followed by (partial) re-qualification
- Re-pair plans followed by (partial) re-qualification
- Audit-ready documentation
- Application specific System Suitability Tests
PSS PQ Services comprise
- Verification and documentation of the system's ability to meet specified criteria according to a mutually agreed test plan after standard maintenance/repair
- Optional holistic GPC/SEC test with PSS EasyValid GPC/SEC system suitability test
- Design, characterization and manufacturing of reference materials for use as PQ samples