Essential Elements for a GMP Analytical Chemistry Department - Catalano, Thomas; SpringerLink (Online service) (New York, NY : Springer New York : Imprint: Springer, 2013)
Introduction -- Organization -- Department Structure -- Project Teams -- Responsibilities -- Interactions -- Operating Guidance's -- Processes -- Safety -- Technology -- Department -- Statistical Concepts for the Analytical Chemist -- Data distribution -- Significance Testing -- Confidence Intervals -- Outliers in analytical data -- Regression -- Experimental design -- Required sample replicates -- Method performance -- Uncertainty measurement -- Sampling strategies -- Outsourcing -- Process -- Audit Check List -- Documentation -- Sample Submission -- Technical Report -- Reports of analysis -- Records (Training etc.) -- Job Descriptions -- Career Tracks -- Motivating Personnel -- Career Path -- Hiring the Best.
Keywords: Pharmaceutical technology; Pharmaceutical Sciences/Technology.