Essential Elements for a GMP Analytical Chemistry Department

• Κύριος συγγραφέας: Catalano, Thomas (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: New York, NY : Springer New York : Imprint: Springer, 2013.
• Θέματα: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

 Essential Elements for a GMP Analytical Chemistry Department identifies the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction, thereby encouraging the sharing of ideas, skills, and abilities among department personnel.  The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, statistical concepts, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. Essential Elements for a GMP Analytical Chemistry Department can be an asset to many companies required to perform GMP analytical method development, validation, analyses, documentation, etc…. 

 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.