One of the largest pharmaceutical companies in the world recently turned to AM Technical Solutions (AM) to deliver Commissioning, Qualification, and Validation (CQV) solutions to support innovation and manufacturing at two facilities.
Our client is expanding and building new facilities on the East Coast and Midwest. These are large capital projects that require specific expertise and the right leadership to define and successfully implement the CQV program.
For the East Coast project, we are providing CQV skills to help bring the program to fruition. For the Midwest project, we are providing leadership for the CQV program to support their capital project efforts. We anticipate meeting the client’s needs with a first-time-right approach to support their rapidly-growing pharmaceutical research and manufacturing efforts.
Our Specific Support Providing CQV Solutions
The scope of both projects is to help define, execute, and deliver a successful CQV program that supports two key objectives:
- Lead the CQV program to meet all regulatory requirements within the cost and schedule plans of the capital project.
- Structure the effort such that all project elements involve CQV efforts from the beginning of the project lifecycle to assure First-Time-Right.
To support these objectives, we are providing highly qualified personnel to support Architectural & Engineering Design, Engineering, Construction, Startup, and CQV. We will help the client meet oversight requirements outlined in the FDA regulations and governed by international health agencies.
Our subject matter experts (SMEs) have intimate knowledge of the ASTM E2500 risk-based approach for the specification, design, and verification of pharmaceutical manufacturing systems and equipment to ensure that each facility is suitable for use. Our SMEs also understand how to integrate quality into the initial phases of the project lifecycle.
“We are confident that we will hand over optimal facilities that will meet our client’s requirements, adhere to all quality and compliance guidelines, and will stay within the budget and timeline of the project milestones,” says Brian Williams, SVP AM Life Sciences. “We look forward to supporting our client’s innovative research and manufacturing efforts as they strive to meet the latest health needs of individuals in the U.S. and around the world.”
– Find out more about our capabilities to deliver CQV solutions and process validation for pharmaceutical companies.
– View our portfolio of completed, award-winning high-tech construction projects.
– Need CQV solutions for your pharmaceutical facility to meet FDA requirements? Contact us today to discuss your project requirements.