AM Technical Solutions (AM) recently won a significant Quality Assurance (QA) project for a major pharmaceutical manufacturing company in the Western U.S.
The biopharma manufacturer needed just-in-time provision of QA services to replace their previous service provider. Our role was primarily to provide quality verification to meet regulatory compliance requirements.
We were brought in based on our proven performance on executing with a First-Time-Right for Quality, Schedule, and Budget, as well as our expertise and ability to adapt to projects that are already underway. We were asked to work with the customer’s project manager to keep the project moving forward and on-time. This was critical because the pharmaceutical facility materials had already been ordered and awaiting inspection before further work could be completed.
Our Scope of Work for the Biopharma Manufacturing Project
We worked with our customer to establish a scope of work to support their project needs. The scope included the following key elements.
- We provided verification of items to specifications. This included 100% inspection of all procured components, 100% inspection of all piping welds with borescopes, and providing the necessary documentation evidence.
- We inspected and established a defined chain of custody for material and its related documentary evidence.
- We tracked down any required information on valves or parts that were furnished by the customer to ensure that all the required documentation was utilized.
- Utilizing an electronic cloud-based documentation platform for an Electronic Turnover Package (ETOP) allowed for efficient (search) access and cross-references for verification and historical records evaluation.
-- Our platform provided access for multiple users to view documents concurrently to speed up the project timeline. This prevented the time-consuming and challenging process of passing along binders between multiple people on the validation and owners team.
-- Our platform provided real-time visibility to all turnover documentation to support in-process commissioning and qualification activities to avoid a massive documentation dump on the backend of the project.
- We helped the customer’s project manager and the validation team effectively execute their project plan by allowing their team to get involved early, therefore avoiding issues further downstream in the project lifecycle.
Because the project was fast-tracked to meet the customer’s timeline, we worked hand-in-hand with the validation team to provide them with a physical and electronic TOP as systems were getting completed.
“Our team showed exceptional teamwork and commitment to complete the QA project for our customer,” says Rob McAndrew, VP of Global Accounts. “We are a different QA company than what our customer experienced before, which captures our position in the market as a global leader in QA services for pharmaceutical manufacturers.”
“I am exceptionally proud of our team for bringing together our experience, tools, and first-time-right approach to work with the customer’s project manager and other stakeholders to complete the project to their satisfaction,” says Gilbert Sanchez, AM Construction Coordinator.
- Find out more about our Quality Assurance and Quality Control capabilities for biopharma.
- View our Portfolio of completed QA/QC projects for biopharma customers.
- Contact us today to discuss leveraging our team’s capabilities and expertise to support your pharmaceutical manufacturing project needs.