| 书目名称 | Essential Elements for a GMP Analytical Chemistry Department | | 编辑 | Thomas Catalano | | 视频video | | | 概述 | Describes a systematic approach to establishing an effective GMP analytical department.Discusses the development and management of project teams.Describes an outsourcing process to ensure all activiti | | 图书封面 |  | | 描述 | .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. | | 出版日期 | Book 2013 | | 关键词 | GMP; SOP; operating guidance; regulatory guidance | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4614-7642-9 | | isbn_softcover | 978-1-4899-9674-9 | | isbn_ebook | 978-1-4614-7642-9 | | copyright | Springer Science+Business Media New York 2013 |
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发表于 2025-3-21 18:08:21
