Construction & Project Management Challenges
In this competitive landscape, flexibility and speed to market are just a few of the challenges we can help you overcome. Learn how PMA has helped deliver pharmaceutical projects.
GENERAL PHARMACEUTICAL INDUSTRY
PMA was engaged prior to project funding to provide third-party estimate reviews for all major capital projects in the United States, Puerto Rico, and in Mexico; project costs ranged between $5 million and $150 million. Facility construction types included research and QA/QC laboratories, chemical production, secondary manufacturing and packaging, and biological. Typical reviews included analyses of both high-level indicators as well as detailed metrics (e.g., hours, lf of pipe).
PMA provided schedule and risk analyses assistance on a $250 million biopharma production facility. To meet the requirements of a systems turnover-based schedule so that commissioning, qualification, validation, and regulatory affairs teams could refine strategies, PMA assisted with the early development of the schedule for all qualification and process validation activities. Once the integrated schedule was complete, PMA performed schedule risk analyses, including a Monte Carlo simulation, to reflect the likelihood of the project achieving desired milestones.
PHARMACEUTICAL & BIOTECH LABORATORIES
PMA was retained to analyze and determine the merits of more than ten claims, ranging in value from $15,000 to $10.9 million, submitted by construction service contractors on a new $600 million pharmaceutical laboratory and manufacturing facility. Claims involved work by multiple prime contractors, including piping, instrumentation, electrical, concrete, HVAC, and mechanical. This project is comprised of a laboratory building, pilot plant, administrative building, visitor center, warehouse, energy center, wastewater treatment plant, and several other buildings and associated infrastructure.
The project entails facility design and construction of a new production unit within an existing launch manufacturing facility. Total cost for the project was approximately $40 million with a total schedule of 22 months from the beginning of conceptual design through start-up of the facility. PMA provided project management controls and cost estimating services that involved the following:
Per the request of senior management, PMA was asked to provide an independent review of two major secondary manufacturing projects, focusing on risks to the construction management project, validity of the latest cost forecast/estimate, and the schedule to complete.
Each review involved a detailed investigation at the project site and included interviews with key project team personnel and a review of relevant project documents. The PMA review team, focusing on areas of concern, performed detailed analyses of issues and risks to help develop an accurate status of the project.
Detailed analyses included the following:
- Review of the cost forecast for completeness, accuracy, up-to-date information, and methodology of projections
- Review of the schedule to ensure it was representing the project status, was accurate for predicting the path forward, and that sound practices were being followed
- Review of the change order status and system
- Assessment of contingency
- Assessment of risks, possible impacts to project cost and schedule, and potential mitigation steps
- Review of the organizational structure, roles, and responsibilities