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The Montrium Blog

The most helpful and thought-provoking ClinOps content from our writers on the front-lines of the life sciences industry

The quality of a drug is only as good as the quality of its development and manufacturing processes, which is why life sciences organizations far and wide have turned to a concept known as "quality by design" (QbD). QbD aims to ensure that every step of the drug development process meets certain pre-defined standards that have been carefully selected and thoroughly researched. The pharmaceutical industry has been using quality by design for years now, but it wasn't until relatively recently that we began to see a massive boom in the adoption of QbD methodology—fuelled in part by ICH E6(R3), no doubt. So, what exactly is quality by design? And why should you care?


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