Operational Qualification/ Performance Qualification for ...

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Operational Qualification / Performance Qualification for HPLC Instruments Operating Instructions Version: Date: Oktober 2008 2008 DIONEX Doc.: OQ and PQ Operating Instructions OQ and PQ Operating Instructions Table of Contents 1 How to Use this Manual ........................................ ........................................ ....1 2 Defining the Limits ........................................ ........................................ .......................................3 Operational Qualification (OQ) ........................................ ........................................ ...............3 Performance Qualification (PQ) ........................................ ........................................ .............3 System Suitability Check (SSC; also: System Suitability Test, SST).

2.1.2 Performance Qualification (PQ) The purpose of Performance Qualification is to prove and document that an analytical system functions according to a specification that is suitable for the system's routine operation. As a system is subject to wear when being operated, it may happen that the supplier's specification is no longer met.

  Performance, Qualification, Performance qualification