Quality by Design
Quality by Design (QbD) is a systemic approach to pharmaceutical drug development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Applying QbD during drug development is more and more expected by regulatory authorities and the use of QbD elements is required by the FDA and the EMA since respectively 2011 and 2012.
QbD 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 capability and continual improvement
Implementation of QbD will lead to a better understanding of the process. It requires the collaboration of research, development, manufacturing, QA, QC and RA at an early stage. It will enable the transformation of the chemistry, manufacturing, and controls (CMC) review of a new drug application into a science-based pharmaceutical quality assessment. Furthermore, QbD has also large advantages during the commercial phase of the drug. Thorough product and process knowledge will lead to a robust process with less deviations and batch failure (“right-first-time”). In addition, it provides opportunities for more flexible regulatory approaches with less post-approval submissions (manufacturing changes within the approved design space without further regulatory review). Thus by applying QbD, product and process knowledge will increase and will lead to a continuous improvement over the total product life cycle.
Progress-PME employees are very experienced in the product development field. They have knowledge of laws, regulations and guidelines with respect to the QbD methodology and furthermore an extensive knowledge of applying QbD during product and process development. In combination with their strong project management skills they can support you to gain a thorough drug and process knowledge which will minimize the “time-to-market” and will lead to a robust process.