White Paper

Quality By Design And Design Control Roadmap For Combination Products

By Ana Ladino, West Pharmaceutical Services, Inc.

Planning Quality Into Clinical Trials: Integrating RBM And QbD

Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. Its systematic framework begins with predefined objectives, and emphasizes product and process understanding. It really enables manufacturers to focus on what matters the most, Quality should be built in the design, it cannot be tested into products. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

QbD and design control requirements start and end with the patient in mind. They provide principles to define the quality target product profile (QTPP), user needs/design inputs, identify the potential critical quality attributes (CQAs) and use risk assessment tools to determine the link between them. The end goal is to develop safe, high-quality products to improve the wellbeing of patients. The proposed roadmap uses drug and device regulatory guidelines and best practices that complement each other to address the complex and evolving combination product development process from concept to commercialization.

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West Pharmaceutical Services, Inc.