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Performance Qualification

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
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