QbD for biopharmaceutical product lifecycle management
European Pharmaceutical Review
APRIL 21, 2025
In fact, the QbD approach promotes such a robust process control strategy that many regulatory bodies, such as the FDA 2 and EMA, encourage implementation of QbD for risk and quality management. Internet] FDA. 3 The detailed characterisation by QbD approaches ensures that safe and high-quality biologics are consistently produced.
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