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Operational Qualification/ Performance Qualification for ...

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)..3 Basic Requirements for Successful OQ and PQ.

For a description of the Operational Qualification (OQ) and Performance Qualification (PQ) procedures, refer to the sections below. 2.1 Defining the Limits According to "The development and application of guidance on equipment qualification of analytical instruments" of P. Bedson and M. Sargent [Accred. Qual. Assur. (1996) 1: 265 - 274] the ...

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