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Labcompliance News, August 1998

Aug 1, 1998

Article: Validation of Analytical Methods

LC/GC International, February 1998, 96-105
Author: Ludwig Huber
Summary recommendations: The process of analytical method's validation should demonstrate that the method is fit for its purpose. The validation should follow a plan that includes the scope of the method, the method performance characteristics and acceptance limits. Parameters usually examined in the validation process are limits of detection and quantitation, accuracy, precision, selectivity/specificity, linearity, range and ruggedness. A validation report should be generated with all experimental conditions and the complete statistics. When 'standard' methods are used in the laboratory, their scope should be in line with the scope of the laboratories' method requirements and the suitability of the entire analytical system in the specific laboratory's environment should be verified for the method. Order from libraries or download draft version from LabCompliance User Club order an electronic copy through e-mail.

Aug 1, 1998

Article: Equipment Qualification in Practice

LC/GC Magazine, Vol 16, February 1998, 148-156.
Author: L. Huber,
Summary recommendations: Equipment qualification starts with the definition of the instrument's intended use, its required functions and its operational specifications. This first step is called design qualification. The installation process should be documented and the instrument tested for its previously defined specifications before routine use. These two steps are called installation qualification and operational qualification respectively. During routine use, the equipment is tested on a frequent basis, as part of the complete analysis procedure, to make sure that it continually delivers high quality results. This final step is called performance qualification. The article provides an overall strategy for the entire equipment qualification. LC/GC Magazine, Vol 16, February 1998, 148-156. Order from public libraries using the above mentioned reference. Order from libraries or download draft version from LabCompliance User Club.