In this chapter, an organizational structure is proposed which will allow for a more efficient and effective Analytical Department. The organization is based on a project team model. Discussions on how the team is formed, managed, and the utilization of team dynamics are presented in detail. A process for project risk evaluation based on the project plan is proposed. Among the most basic essentials, and a requirement, in any successful GMP Analytical Chemistry Department is the establishment of Standard Operation Procedures (SOP’s) and working Guidelines. This is the most efficient way to communicate best practices within the group. The essential SOP’s that should be included within a GMP Analytical Chemistry Department is listed within the chapter, along with a template for writing SOP’s.


Team Member Project Plan Team Leader Active Pharmaceutical Ingredient Analytical Department 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.PharmChem Analytical Consultants, LLCBuffalo GroveUSA

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