AM Life Science (AMLS) recently partnered with a Boston-area gene therapy company to insert a Commissioning Qualification and Validation (CQV) subject matter expert (SME) at the pre-construction/construction phase of the facility design/build project.
The insertion of a downstream SME aligns with our unique approach to Quality by Design (QbD) called Early Quality Integration (EQI). Our approach helps clients align with FDA approval requirements from the onset of a commissioning, qualification, and validation (CQV) project.
Our Unique Approach to QbD Achieves Understanding
The SME will be a source of knowledge of downstream requirements in the gene therapy clinical/commercial facility renovation project. This will allow decisions to be more well-rounded and evaluated for impact.
Phase gate tasks will also be verified to be sufficiently completed prior to turnover to the CQV phase, leveraging any and all completed evaluations.
This overall process ensures that work meets all requirements before being designated as complete, resulting in significant reduction in rework, cost, and schedule.
The process also creates an understanding of the “why” behind living process needs and how facilities, equipment and processes are controlled. This ensures that each step contributes to a facility and product that consistently meets specifications.
Download the eBook On Our QbD Approach
Learn more about how AMLS follows and applies QbD in each project to support FDA approval for pharmaceutical companies. We invite you to download our whitepaper on Early Quality Integration to understand our process and how we can support your next project.
