4. How to set up OQ or PQ tests

Over the last ten years, the increasing attention paid by regulatory authorities to equipment qualification has forced manufacturers of analytical equipment to play a growing role in the various stages of qualification, and to propose tests. In the absence of tests, or in order to better adapt tests to the intended use, an approach can be proposed which consists of :

• study the equipment (its various modules, operating mode, operational and functional specifications provided by the manufacturer); a good technical knowledge is required;

• define device usage (e.g. trace analysis) ;

• consult existing literature (articles; books; norms and standards; manufacturers' maintenance manuals and documents; pharmacopoeias, etc.) and obtain information from the manufacturer;

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