An interesting article by Zachary Brennan on outsourcing-pharma.com highlights the current status in the adoption of quality by design (QbD) methods for clinical research. According to the results of a survey presented at this year’s Avoca Quality Consortium Summit, half of respondents have a “good understanding” of QbD principles, however 24% have yet to begin implementing QbD. Additional results suggested that internal infrastructure poses a major challenge to the adoption of QbD, although 30% of respondents claim to be establishing a foundation for QbD principles for clinical research and development. Representatives from both Eli Lilly and Pfizer provided additional insight on their progress; the common challenge among both companies is the thought process behind QbD practices.
The article provided additional advice from respondents on how companies can better manage the challenges associated with QbD implementation:
- Make sure you’re assessing the suppliers and understanding their experience and expertise in adopting QbD
- Deploy best practices for conducting supplier risk assessments for outsourced services
- Joint collaboration with partners to ensure appropriate implementation of QbD
- Build QbD methodologies into vendor contracts
To read the full article, click here. Need help with QbD? Email us at info@pearlirb.com .