Analytical Chemistry in a GMP Environment

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In the face of increasing regulatory pressures in the pharmaceutical industry, there is a pressing need for skilled analysts who can uphold scientific practices in laboratories and manufacturing sites globally. This practical guide, rooted in Johnson & Johnson's esteemed in-house training program, offers essential insights for laboratory analysts navigating the Food and Drug Administration's good manufacturing practices (GMP) alongside evolving analytical technologies. Industry experts provide a step-by-step approach to the concepts, techniques, and tools necessary for conducting analyses in an FDA-regulated setting. The guide includes clear instructions on major analytical chemical methods, such as spectroscopy, chromatography, and dissolution. It serves as both a formal training manual and a self-study resource, covering topics like the drug development process, uniform interpretation of GMP compliance, the role of statistics in analytical chemistry, and a focus on high-performance liquid chromatographic (HPLC) methods. Additional chapters address detectors, quantitative analysis, and data systems, along with methods to ensure instruments adhere to standard operating procedures (SOP). Extensive appendixes unify terms, symbols, and procedural information, making it a comprehensive resource for analysts in the field.