HunterLab Instruments In The Pharmaceuticals Industry

Complying with FDA Documentation Regulations

HunterLab instruments, particularly the ColorQuest XE, LabScan XE, UltraScan XE, and UltraScan PRO, are gaining popularity for the color measurement of tablets and powders (in reflectance) and liquid solutions (in transmittance) associated with the pharmaceuticals industry. When an American pharmaceutical company purchases new measuring equipment of any type (liquid and gas chromatographs, for example, in addition to color measurement instruments), they must give special consideration to the documentation requirements of the United States Food and Drug Administration (FDA). These requirements will vary from company to company, as each pharmaceutical company is responsible for defining and maintaining its own documentation requirements list. Some areas to consider and their HunterLab solutions are discussed in the sections below, and a checklist of items that may be required is provided on the last page. Since HunterLab also sells to a number of industries that do not require such extensive documentation, it is not automatically included or its cost bundled into system prices. Therefore, some additional fees may be involved.