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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.

according to its operating specification while the specific environmental conditions are taken into account. In his specification, the supplier must therefore define exactly the conditions that must be observed. With varying conditions, e.g. different ambient temperatures, higher limits …

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