By Robert Garner, Vice President BioPharma Business Unit at Jedson Engineering
Every pharmaceutical project is unique and each project requires a detailed Project Execution Plan (PEP). The PEP is not a “one size fits all” document. It must be specifically tailored to meet the size and specific phases of an individual project.
While attributes that are common to all projects include safety, quality, cost, and schedule, each project combines differences in scope, scale, complexity, resources, and many other factors to achieve its goals and objectives. During the project development and delivery process, the concept and Basis of Design (BOD) phases of work are important alignment phases of project execution which help to address these attributes as well as many addressed within the PEP. The PEP communicates and documents the project “map” and the overall strategic approach for the execution of the entire project for all stakeholders. It also sets the tone for demonstrating effective leadership, project organization, progress measurement, and teamwork. A good PEP provides guidance over every applicable element of a project. Such attention to detail is particularly important for the pharmaceutical industry, which faces regulation from the U.S. Food and Drug Administration (FDA) in the form of current Good Manufacturing Practices (cGMP) regulations. A PEP is the product of good project planning and incorporates several sub-plans, such as a project procurement (or supply management) plan, project risk identification and mitigation plan, project staffing plan, construction execution plan, cost/budget management plan, project controls plan, project quality plan, and overall team alignment.
This Article is published with permission from the International Society of Pharmaceutical Engineering (ISPE), and Pharmaceutical Engineering Magazine