Implementing Quality by Design (QbD) Principles in Clinical Trial Supply Management with CDMOs

Quality by Design (QbD) is a systematic approach to pharmaceutical development that emphasizes the importance of designing quality into products and processes from the outset. Contract Development and Manufacturing Organizations (CDMOs) play a critical role in implementing QbD principles in clinical trial supply management, ensuring the quality, safety, and efficacy of investigational products. Let's explore how CDMOs leverage QbD principles in clinical trial supply management:

Risk-Based Approach: CDMOs adopt a risk-based approach to identify and prioritize critical quality attributes (CQAs) and process parameters that can impact the quality, safety, and efficacy of investigational products. By conducting risk assessments and leveraging scientific knowledge and prior experience, CDMOs identify potential risks and implement control strategies to mitigate risks and ensure product quality