Selecting parameters and limits for equipment operational qualification |
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Authors: | L. Huber Lou Welebob |
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Affiliation: | (1) Hewlett-Packard, D-76337 Waldbronn, Germany Tel.: +49-7243-602209; Fax: +49-7243-602501; e-mail: ludwig_huber@hp.com, DE;(2) Hewlett-Packard, 371 Hoes Lane, Piscataway, NJ 08854, USA Tel.: +1-980-562-5246; Fax: +1-908-562-6246; e-mail: lou_welebob@hp.com, US |
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Abstract: | While operational qualification (OQ) is a well-established term within equipment qualification, users of equipment often become unsure when it comes to implementation. The biggest problem is how to select procedures and acceptance criteria. Should these be the vendor's specifications or should the users define their own limits, and, if so, how? Should all instruments of the same type have the same values or should these be optimized for each individual instrument? This article will provide an overall strategy and specific examples for HPLC on how to select procedures and acceptance limits that are based on efficient use of resources, on practicality and on the intended use of the equipment. |
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Keywords: | Equipment qualification Operational qualification Implementation Acceptance limits Procedure selection Abbreviations AU Absorption Units DQ Design qualification IQ Installation qualification OQ Operational qualification PQ Performance qualification RSD Relative standard deviation RT Retention time |
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