Making the Most of Your Scale Down Model

In 2002 the US Food and Drug Administration began its initiative to modernise the regulation of pharmaceutical manufacturing and product quality and initiated the concept of Quality by Design (QbD) for pharmaceuticals. QbD principles and advice for implementation are outlined in regulatory guidances such as ICH Q8, Q9 and Q10. One of the foundations of QbD, underpinning its operation is that products and processes are sufficiently understood so that those elements most critical for product quality can be identified, codified and controlled.

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