Initiating a pharmaceutical capital project requires a deep understanding of the unique processes related to current good manufacturing practices, along with experience in the design, procurement, construction, commissioning, qualification, and validation of facilities, utilities, and equipment. Additionally, planning should account for the regulatory affairs that approve bringing a product to market in this highly regulated industry. While most of the pharmaceutical capital projects are schedule-driven in a first-to-market business model, improper planning and delays constantly jeopardize the release of new products.
This paper describes practical techniques to plan and schedule new construction and renovations of existing buildings; typical sequences and durations used for commissioning, qualification, and validation activities; timing for engagement with different stakeholders; common pharmaceutical terminology employed during all phases of a project; and recommended approaches to leverage previously performed work to potentially gain time in the project schedule. Novice and seasoned practitioners alike will benefit from following these procedures. The author has successfully used these practices in manufacturing facilities for oral, parenteral, and topical administration products located in the Americas, Europe, and Asia.
By: Francisco Cruz Moreno, PE
2021 AACE® INTERNATIONAL TECHNICAL PAPER