Quality by Design (QbD): Beyond Mere Compliance

Quality by Design (QbD) principles have been incorporated into regulatory guidelines for over two decades, so regulated life science companies are familiar with the requirements and how to meet them. Predating QbD, our industry and others were using similar principles with great success even without the regulatory requirement to do so. They deployed the practices since they positively impacted the bottom line.

Thus, our industry should not view QbD as a box ticking exercise, since fully integrating QbD principles into a company’s culture and Chemistry Manufacturing and Controls (CMC) operations has benefits to business outcomes:

• Enhanced Product Quality and Consistency: QbD principles ensure consistent and high-quality products by identifying and controlling critical quality attributes and process parameters.
• Reduced Risk of Manufacturing Failures: Proactive risk identification and robust control strategies mitigate manufacturing failures and/or product recalls.
• Cost Savings and Efficiency: QbD reduces the need for extensive end-product testing and minimizes waste, resulting in lower production costs and faster time-to-market.
• Faster Regulatory Approvals: Adhering to QbD principles demonstrate a thorough understanding of the product and process that leads to timely regulatory approvals.
• Continuous Improvement and Innovation: QbD fosters a culture of continuous improvement and innovation which leads to better products and efficient manufacturing processes.
• Improved Supply Chain Management: QbD ensures consistent quality standards in raw materials and intermediates, reducing supply chain disruptions.
• Optimized Resource Allocation:-The risk-based approach essential to QbD focuses resources on product attributes of most importance, saving time, effort, and money.
• Better Decision-Making: A strong foundation in QbD enables better informed decisions from development to commercial manufacturing.

With these business advantages in mind, we have identified seven ways companies can move beyond compliance and fully embrace and incorporate QbD into their operations and culture:

• Implement the Foundation: First, establish a QbD and risk-based lifecycle strategy and policy with written policies and procedures.
• Proactive Implementation: Enhance understanding of processes and products through risk assessments, identifying critical quality attributes (CQAs), and robust control strategies.
• Data Management: Implement a lifecycle document management strategy and IT systems that enable access to and use of process and manufacturing data, for example Factorian’s Edge platform (https://mind-device.com) is one means to aid digital transformation.
• Continuous Improvement: Regularly review and update processes based on new data and insights.
• Cross-Functional Collaboration: Foster a culture of teamwork and open communication across departments.
• Advanced Technologies: Utilize real-time analytics, process analytical technology (PAT), and automation for better understanding and control of manufacturing processes. Again, Factorian’s Edge platform (https://mind-device.com) in one means to power this initiative.
• Training and Education: Continue to ensure employees understand QbD principles and their role in its implementation.

Do you need help with CMC challenges or QbD strategy and implementation? Please contact Windshire at info@windshire.com or +1 844-686-5750 to determine how we can support your needs.