There is growing appreciation within the pharmaceutical industry that late-stage QC testing may not be the most effective or efficient way to deliver quality products. After all, quality cannot be ‘tested’ into a product – it should be there by design. As a result, many companies are adopting a quality-by-design approach (QbD) to product development, underpinned by systematic, data-driven strategies.
In an article published in Pharmaceutical Technology, Dr Martin Koeberle (Head of Analytical Development &Stability Testing) and Wolfgang Schiemenz (Senior Manager of QbD & Drug Regulatory Affairs) discuss:
- The fundamental principles of QbD and how they can be adopted in pharmaceutical development
- How a QbD approach can simplify regulatory compliance and enable manufacturers to operate within a broader design space
- How QbD can simplify scale-up and reduce development risk
- How real-time release testing can enable developers to increase output, reduce throughput times, and lower costs