AM Technical Solutions (AM) is supporting a critical facility expansion project for a specialty pharmaceutical company in the Northern U.S.
The customer leverages their expertise in medical technology to support various healthcare treatments. To meet a growing need in the market, the customer needed full turnkey services to support the production of rapidly-expanding medical device products. This included needing to build out warehouse and packaging lines.
This project was broken into two phases to ensure the delivery of necessary services in an efficient and compliant manner with a focus on schedule, cost, functionality, and quality. We completed Phase 1 of the project, which included an initial assessment of their facility startup, commissioning, and qualification program.
We are currently supporting Phase 2 of the project, which consists of program development for their C&Q program and execution of facility expansion plans to support their growing medical device production.
Phase 1 Project Scope: Validating Facility Expansion
The specialty pharma company initially sought support from our company to build their C&Q program as well as assess their existing systems, equipment, and project schedules. This front-end work paved the way to facilitate the startup, commissioning, qualification, and validation in support of their new warehouse and MFG space build project.
Our company was able to step in to provide critical support because of our strong team performance, the availability of industry-leading talent to fill specific roles, our project management delivery approach, and our ability to provide services that aligned well with the customer’s timelines and goals for the project.
After successfully completing this initial assessment, we were well-positioned to continue supporting the client during Phase 2 of the project.
Phase 2 Project Scope: Program Development
We are currently supporting program development for the customer’s C&Q program. Specifically, we are providing project management services for the customer’s CQV activities related to the following areas:
- Equipment and utilities
- Generation of C&Q protocols
- Risk assessments
- Program Standard Operating Procedures (SOPs)
- Execution of CQV protocols and engineering studies
Then, looking ahead to future needs, the customer has engaged our team to provide Materials Management & Warehouse Management, Technical Writing, Process Engineering, and Facility Engineering expertise to support ongoing operations at their expanded facility.
“We are proud of our team’s commitment to supporting each phase of the project with a first-time-right mindset to support our customer’s objectives,” says Brian Williams, SVP, AM Life Science. “We look forward to continuing to provide ongoing support as the customer takes advantage of their expanded facility to support innovative medical device production.”
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