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Paul Smith is EMEAI laboratory compliance productivity specialist at Agilent Technologies UK Ltd, 610 Wharefedale Road, IQ Winnersh, Wokingham, Berkshire RG41 5TP, United Kingdom, email@example.com
What does risk assessment in the context of the life cycle of a high performance liquid chromatography (HPLC) instrument really mean? This article looks at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ). The relationship between PQ and OQ and the design qualification (DQ) phases of the life cycle are also explored.