Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach

• DOI: 10.1007/bf02830588
• Publication Date: 2008-11-17T13:58:56Z
• Authors: Surendra K. Bansal; Thomas Layloff; Ernest D. Bush; Marta Hamilton; Edward A. Hankinson; John S. Landy; Stephen Lowes; Moheb M. Nasr; Paul A. St. Jean; Vinod P. Shah
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 01 natural sciences; 0104 chemical sciences

The purpose of the use of analytical instruments is to generate reliable data. Instrument qualification helps fulfill this purpose. No authoritative guide exists that considers the risk of instrument failure and combines that risk with users' scientific knowledge and ability to use the instrument to deliver reliable and consistent data. In the absence of such a guide, the qualification of analytical instruments has become a subjective and often fruitless document-generating exercise.