BlogHeader.png
Will Hartley

Will Hartley

William Hartley is the Commercial Development Manager of Drug Product at Alcami. He brings a breadth of experience from multiple contract development and manufacturing organizations; with a commercial focus in both liquid and lyophilized sterile drug product, oral solid dose manufacturing, and commercial packaging operations. William holds a Bachelor of Science degree from North Carolina State University, where he studied molecular biology and biomanufacturing.

Recent Posts by Will Hartley:

Introduction to Quality by Design

Since Joseph Juran’s concept of Quality by Design (QbD) was first adopted by the US Food and Drug Administration (FDA), the pharmaceutical industry has been interpreting its concepts into a variety of approaches for implementation. At Alcami, our QbD approach considers evolving global regulatory guidances with a collaborative fit-for-purpose and pragmatic approach that can evolve throughout the lifecycle of the product. QbD starts from day one in modern product development, culminating in a chemistry manufacturing controls (CMC) package that maximizes every opportunity for a successful regulatory review and approval. The value of this approach is simple: design of robust processes for the consistent production of safe and effective products for our patients and long term cost savings for our partners through improved yields, reduced deviations, and efficient change management.

The QbD process for product development is intended to build quality into pharmaceuticals based on characteristics that define safety and efficacy. Critical quality attributes (CQAs) – specific physical, chemical, biological, and other properties – may impact product safety and efficacy and can be managed by identifying critical process parameters (CPPs) through the use of risk management tools and controlling them within the proven acceptable process design space.

Topics: Thought Leadership Regulatory Compliance Manufacturing Development Drug Product