AM Life Science (AMLS) promotes an approach to quality by design (QbD) that we call Early Quality Integration (EQI). The goal of this process is to better support biotechnology companies meet FDA requirements.
We are now partnering with a Boston-area biotech company to insert a Validation and Quality subject matter expert (SME) at the pre-construction/construction phase of a tech transfer project.
Inserting a downstream SME in the project aligns with our unique approach to QbD. Our signature EQI approach helps clients align with FDA approval requirements from the onset of the project. This ensures that issues are addressed before construction begins, not later in the project when delays and additional costs cannot be tolerated.
How We Execute Our Approach to Quality by Design
Our resource will be a source of knowledge of downstream requirements, allowing decisions to be more well-rounded and evaluated for impact. Additionally, phase gate tasks will be verified to and sufficiently completed prior to turnover to the Commissioning, Qualification, and Validation (CQV) phase, leveraging all completed evaluations.
This process will create assurance for the biotech company that the work meets all requirements before being designated as complete, resulting in a significant reduction in rework, cost, and schedule.
Our approach to Quality by Design also helps stakeholders focus on the “why” of understanding the living process needs and how equipment and processes are controlled. The result is full assurance that each step contributes to a product that consistently meets specifications.
Read Our Whitepaper on Early Quality Integration
To learn more about how we follow and apply QbD principles to each project to support FDA approval for pharmaceutical companies, we invite you to download our whitepaper on Early Quality Integration.
After reading the whitepaper, please contact the AMLS team to discuss how we can integrate our capabilities and resources with your next project.