Maintaining a reliable supply of prescription drugs can make a significant difference in the lives of people across the world. Patients depend on timely access to the medication they need, and even brief disruptions in supply chains can have serious downstream effects.
AM Technical Solutions (AM) is helping close the gap by providing Quality Engineering (QE) support services for a leading U.S. pharmaceutical company. Our team of experts will work closely with our client at their facility to help validate drug manufacturing operations.
Our goal is to help the company meet regulatory and performance standards, ensuring that patients receive the necessary medications at the right time. Learn how we plan to use our deep technical expertise and decades of FDA-regulated project experience to support our client’s production schedule.
Our Quality Engineering Support for Critical Pharma Operations
Our approach to Quality Engineering is all about agility, collaboration, and results. Our support model is designed to meet aggressive safety, cost, schedule, and quality benchmarks – without compromising flexibility or communication.
We have been contracted to provide the following critical services to support our client’s initiative:
- Partner with validation teams to develop and pre-approve validation documents.
- Review and approve executed validation protocols for equipment, utilities, cleaning, and manufacturing processes.
- Ensure all validation activities align with current regulatory standards.
- Participate in risk assessments and identify Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- Collaborate cross-functionally to support the commissioning and qualification of new equipment and systems.
- Investigate deviations, non-conformances, and change controls related to validation activities.
These services are designed to help our pharmaceutical client maintain full compliance while proactively identifying and resolving issues that could lead to production delays or shortages. What sets us apart is the capabilities of our people.
For this project, we will deploy a seasoned Project Sponsor with extensive experience in biotech manufacturing and a skilled Quality Engineer who brings deep knowledge of validation and hands-on technical expertise. They will serve as a seamless extension of our client’s team by sharing accountability, promoting transparency, and maintaining alignment on shared outcomes.
“Our people-first, quality-driven approach will allow us to deliver on all three (cost, time, and quality) for this critical project to support pharma production,” says Brian Williams, SVP, AM Life Sciences. “We understand the ramifications for the availability of critical medicines, and we are eager to do our part to help our client increase access to prescription drugs.”
– Find out more about our capabilities to support high-tech construction projects in the Life Science market.
– View our portfolio of award-winning Life Science projects.
– Does your company need quality engineering services to support pharmaceutical production? Contact us today to discuss your latest project needs.