Life Cycle Risk Assessment of HPLC Instruments

July 1, 2017
Paul Smith , R.D. McDowall

LCGC E-Books

Volume e5, Issue 4

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.
 

Read more in LCGC’s new eBook, Reduce Risk in a Data Integrity World:Approaches to Ensure Compliance.