Quality by Design (QbD) is a systemic approach to pharmaceutical drug development that starts with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. The application of QbD during drug development is increasingly expected by regulatory authorities and the use of QbD elements has been required by the US FDA and EMA as set out in Q8(R2) Pharmaceutical Development.

Quality by Design elements include the following:

• a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product;
• product design and understanding, including identification of critical material attributes (CMAs);
• process design and understanding, including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs;
• a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product, as well as controls for each step of the manufacturing process;
• process capabilities and continuous improvement.

Implementation of Quality by Design will lead to a better understanding of the process. It requires the cooperation of research, development, manufacturing, QA, QC and RA at an early stage. It will enable the transformation of the chemistry, manufacturing, and controls (CMC) assessment of a new drug application into a scientifically based pharmaceutical quality assessment. Furthermore, QbD also has great benefits during the commercial phase of the drug. Thorough product and process knowledge will lead to a robust process with fewer deviations and batch errors (“first-time-right”). Additionally, it allows for more flexible regulatory approaches with fewer post-approval submissions (manufacturing changes within the approved design space without further regulatory review). By applying QbD, product and process knowledge will increase and lead to a continuous improvement over the entire product life cycle.

Progress employees have a lot of experience in the field of product development. They have knowledge of legislation, regulations and guidelines relating to the QbD methodology and extensive knowledge of the application of QbD during product and process development. Combined with their strong project management skills (Project Management) they can support you in acquiring in-depth knowledge of medicines and processes, which will minimize time-to-market and lead to a robust process.