Design and Construction of a Dedicated Clinical Supply Facility: An Example of Effective Project Management

Abstract

The pharmaceutical industry commits large levels of financial and human resources to major project efforts for meeting future demands. These efforts must be completed in an increasingly complex, regulated environment. This paper describes how a dedicated clinical supply facility, which manufactures clinical supplies of a sterile antibiotic, was constructed in one year by using The Upjohn Company’s project management approach for conceptual design, facility design, construction, and facility and equipment validation. The facility design and the concept of separateness is addressed here because this facility occupies part of the warehouse in a Penicillin facility and no cross contamination of either Penicillin or the clinical antibiotic is desired. Successful completion of this project required effective utilization of resources and slack time.