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.
KeywordsTeam Member Project Plan Team Leader Active Pharmaceutical Ingredient Analytical Department
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