Abstract
During drug manufacturing, the analytical support function provides scientific and product quality assurance to the predominantly chemical/mechanical functions of manufacturing and packaging activities. Analytical support to manufacturing involves, on a continuing basis, translation of current regulations, evolving technical guidances and pharmacopeia, and analytical procedures and laboratory operations, to meet the scientific, regulatory, and quality expectations for product manufacture. More specifically, analytical testing using appropriate techniques, validated methods, and modem equipment is central to the assurance of the quality of raw materials, in-process controls, and finished product. This article addresses the analytical support required for pharmaceutical manufacturing from active pharmaceutical ingredient (API) synthesis and drug development and approval, through manufacturing and shelf life of the drug product. Key elements of analytical support to manufacturing that are necessary to maintain a state of control during pharmaceutical manufacturing are discussed. Current Good Manufacturing Practice (GMP) and quality systems that are specifically relevant to analytical support to manufacturing are emphasized.
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Velagaleti, R., Burns, P.K. & Gill, M. Analytical Support for Drug Manufacturing in the United States’From Active Pharmaceutical Ingredient Synthesis to Drug Product Shelf Life. Ther Innov Regul Sci 37, 407–438 (2003). https://doi.org/10.1177/009286150303700407
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DOI: https://doi.org/10.1177/009286150303700407