EAN: 9781461476412

ESSENTIAL ELEMENTS FOR A GMP ANALYTICAL CHEMIST...

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   SOP's  regulatory guidance's
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. ?

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