AM Technical Solutions (AM) is helping make a difference in advanced gene therapy research. We were recently engaged by a leading global pharmaceutical manufacturing company to support a large scale capital project that will result in the development of life-saving medicine.
The pharmaceutical company is focused on providing access to medicines that are safe, effective, and affordable. To support this objective, the company is expanding its capabilities at one of its facilities.
The company’s facility is responsible for manufacturing, clinical trials, and commercial materials for conjugate vaccines and gene therapies. To support the execution of the capital expansion project, we were asked to supply an expert who could work hand-in-hand with project teams and provide critical mentorship on industry standards.
We answered the call by providing an industry leader in the ISPE ASTM E2500 methodologies. This expert has been brought on-board to serve as a Commissioning, Qualification, and Validation (CQV) subject matter expert and owner’s advocate. While on-site, the expert will oversee the work being performed by other contractors and ensure project success with a focus on schedule, cost, functionality, and quality.
ASTM E2500 Project Support Focused on Verification
Within the project is a particular focus on verification. During this period of rapid expansion to support gene therapy research, our customer needed an industry leader to help lead and mentor the team in the verification department. Our supplied expert has been asked to provide the following support:
- Review and update the verification project procedures and project plan.
- Ensure procedures and plans reflect current standards and methods of performing work.
- Review and approve SATs, verification testing, engineering changes, and gap assessments.
- Participate in meetings to see where improvements can be made.
- Lead and mentor other project team members.
Mentorship is critical for the successful completion of the project. At the present time, there are very few formal training programs available on ISPE ASTM E2500, as each company interprets and implements their program in a slightly different manner.
The best way to be qualified in ASTM E2500 is to apply hands-on experience on projects that use the methodology in conjunction with being trained by a subject matter expert that already has the experience.
The SME that we supplied for the project has extensive experience with ASTM E2500. Consider this professional’s credentials:
- Started using the ASTM standards even before the official launch in 2007.
- Set up 5 ASTM programs at various companies around the world.
- Relevant expertise to develop standard operating procedures (SOPs), training modules, and templates to support the program.
Our goal is to ensure the overall quality is suitable to support the manufacture and release of a life-saving drug to help patients suffering from a rare disease.
“With the pharmaceutical company expecting a significant workload well into 2021, we are pleased that we could meet their exact need of providing an SME for this project,” says Brian Williams, AMTS SVP of Life Science. “We are confident that their Verification team will benefit from receiving mentorship, coaching, and training that is not readily available in our industry. It’s one example of how we can do right by our customer.”
- Find out more about our capabilities to provide SMEs from our deep bench of professionals to support your CQV needs.
- View our portfolio of completed, award-winning high-tech construction projects.
- Need support for a facility expansion? Contact us today to discuss your goals. We can help!