Abstract
Analytical chemistry is used across the pharmaceutical industry to quantify and identify the components in drug substance, drug product, and raw material to ensure that the final dosage form remains safe and efficacious from lot release throughout the product’s shelf life. To understand any potential shifts in the components impacting safety and efficacy, laboratories require analytical procedures which are reliable, fit for purpose, and executed consistently over time. Analytical procedures provide the instructions used by the analyst to ensure consistent use of laboratory equipment, solution preparation, measurement recording, and documentation. As such, analytical procedures form a critical component in any quality system. This chapter considers statistical methods that ensure that these procedures are fit for their intended purpose.
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Burdick, R.K. et al. (2017). Analytical Procedures. In: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-50186-4_6
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DOI: https://doi.org/10.1007/978-3-319-50186-4_6
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