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 , SOPas, regulatory guidanceas/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. aDistribution of Reference Standard The RSM, or designee, weighs the reference standard material according to the request and labels the container. The label should include, but is not limited to. the Reference Standard number, Class, and anbsp;...
|Title||:||Essential Elements for a GMP Analytical Chemistry Department|
|Publisher||:||Springer Science & Business Media - 2013-06-20|