The Column www.thecolumn.eu.com Vosloo GAMP uses a software-driven classification system2 and focuses on documentation of the qualification evidence rather than direct consideration of the instrument’s application. Although this rigorous approach is beneficial for complex and bespoke software-based analytical instrumentation, its application is less appropriate for general laboratory equipment. In August 2008, general chapter on analytical instrument qualification was issued by the United States Pharmacopeia (USP).3 In a similar way to GAMP, USP applies a classification system but rather than being software-driven, it adopts a risk-based approach. Instruments are classified into three groups; A, B and C. Previous validation approaches concentrated primarily on the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) of analytical instrumentation. In USP this applies Figure 1: Temperature mapping using calibrated probes ensures accurate and consistent qualification results. Graph of temperature stability Figure 2: ‘Open door’ tests allow the equilibration profile of temperaturecontrolled equipment to be monitored. Graph of temperature stability Temperature ( C) 3 1 9 Temperature ( C) Contents Tips & Tricks 2 13 Vosloo Rainville and Mather 6 17 News Meeting Review 8 20 Market Trends & Analysis Events & Contacts