Essential Elements for a GMP Analytical Chemistry Department

• Main Author: Catalano, Thomas. (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic
• Language: English
• Published: New York, NY : Springer New York : Imprint: Springer, 2013.
• Subjects: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.
• Online Access: https://ezaccess.library.uitm.edu.my/login?url=http://dx.doi.org/10.1007/978-1-4614-7642-9

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...

Table of Contents:

• Introduction
• Organization
• Department Structure
• Project Teams
• Responsibilities
• Interactions
• Operating Guidances
• 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.