QbD: Improving Pharmaceutical Development and Manufacturing Workflows to Deliver Better Patient Outcomes

How adopting a quality-by-design (QbD) approach to pharmaceutical development can boost production efficiency and deliver more consistent product quality (article featured in PHARMACEUTICAL TECHNOLOGY EUROPE)

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

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