Design Verification Testing Of Combination Products

By Mike Ulman, Technology Manager, Packaging and Delivery Systems

The article provides a comprehensive overview of the roadmap for developing an injectable combination product, such as a pre-filled syringe or auto-injector. It emphasizes the importance of conducting a risk assessment to determine the necessary tests for the product, as well as complying with regulatory requirements and creating a Design and Development Plan.

The article explains the process of establishing Design Inputs, which involve identifying and addressing various requirements and considerations for the product. This includes conducting risk assessments using different methodologies to assess potential risks and ensure the safety and efficacy of the combination product. Review the importance of identifying Critical Quality Attributes (CQAs) and Essential Performance Requirements (EPRs) that need to be evaluated during the development process.

Design Outputs play a role in ensuring the proper functioning of the combination product. Design outputs include drawings, selected components and suppliers, manufacturing documentation, and other established conditions that lock in the characteristics of the product.