The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
The merits of applying quality by design (QbD) to pharmaceutical products and processes is a topic of significant mutual interest to both pharmaceutical manufacturers and regulatory agencies. The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufacturing processes and to facilitate continuous improvement strategies to shape and enhance product quality and manufacturing productivity. As such, both industry and regulators recognize the benefits of adopting a QbD approach to drug-product development and manufacture, with key concepts described in International Conference on Harmonization (ICH) guidelines Q8(R1) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
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