Essential Elements for a GMP Analytical Chemistry Department [Paperback]

?Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding 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. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOPs, regulatory guidances/guidelines, project teams, technical and department processes, 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. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including?start-up, virtual, and generic pharmaceutical companies. This book outlines planning and implementation of a Good Manufacturing Processes (GMP) analytical program, structured to build an environment and culture that encourages and rewards the sharing of ideas, skills and abilities among department personnel.

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 Deslƒ8