Abstract
Laboratory automation is widely used in the pharmaceutical industry to support quality control, nonclinical and clinical drug development, and drug discovery. Analytical applications for which automation is commonly utilized include dissolution tests, content uniformity and tablet assays, stability tests, aerosol dose tests, biological fluid analyses, toxicological feed analyses, immunological assays, compound syntheses, and receptor-binding assays. Pharmaceutical laboratory applications that utilize laboratory automation can have widely differing means of verifying the quality of analytical performance. Laboratories that fall under the jurisdiction of good laboratory practices (GLPs) or current good manufacturing practices (cGMPs) regulations commonly use instrument calibrations and validations to verify and monitor analytical performance. Laboratory automation is used for the preparation, introduction, and analysis of samples, as well as for the collection, analysis, and reporting of results. This chapter focuses on the validation of automated workstations and robotic systems that are used for sample preparation and introduction. Pharmaceutical laboratory automation most commonly exists as flexible automation.
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