01646nam a22001817a 450000500170000000800410001702000180005804000070007604100080008308200180009110000200010924500650012926000240019430000280021836500620024652011200030865000360142820220329115436.0220317b           ||||| |||| 00| 0 eng d  a9781071605486  cAL  aeng  223a543bCATE  aThomas Catalano  aEssential elements for a GMP Analytical chemistry department  aUSAbSpringerc2020  axiv,195p.bHBc23x15cm.  2Generala6325b₹1356.00c₹d₹1695.00e20%f9-3-2022  aEssential 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.  2Analytical ChemistryaChemistry