Implementation of Quality of Design

Implementation of Quality by Design

Designing Quality into Drug Products

John F. Haury, Ph.D., CQE

Senior Quality Engineer Amgen, Inc., Thousand Oaks, CA

Implementation of Quality by Design

• Amgen’s Vision • Motivating documents from Regulatory Agencies • Brief History of Precursors to QbD • Implementing QbD • Tools and their value to QbD • QbD Example Case • Questions, answers and discussion

QbD = Quality by Design

Amgen’s Vision for Commercialization

• World-class Commercialization means that we flawlessly execute the development, marketing, manufacturing and lifecycle management of products, based on breakthrough science and insightful marketing perspectives to fully address our customer's needs.

Emphasis added by presenter

Amgen’s Vision for Commercialization -continued

• Our Commercial Product Development includes a clear connection between Process Development, Process Characterization and Process Validation. The umbrella over that connection is Quality by Design.

Emphasis added by presenter

Quality by Design=Umbrella

Quality by Design

Process Development A good process recipe

Increasing Process Knowledge

Process Characterization Testing for Robustness Design Space Defined PC

Process Validation Design Space Validated

PV

PD

Motivating Documents

•Quality by Design •Design Space

Towards a Risk- and Science-Based Approach to Pharmaceutical Quality

“To make [the] link [between measurement and risk], we must turn to the science of manufacturing and the concept of quality by design (QbD), which means that product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches. To achieve QbD objectives, product and process characteristics important to desired performance must be derived from a combination of prior knowledge and experimental assessment during product development.”

Woodcock, J. “The Concept of Pharmaceutical Quality” American...