Wednesday, September 26, 2012

“The Scientist Is No Longer In The Laboratory” – sick?

And the introduction to the invitation: The industry is looking at more holistic approaches to improve processes of bringing new products to market that can accelerate product development and lower operational costs. Quality by Design (QbD) has come relatively late to the pharmaceutical industry. In terms of quantifiable benefits, the main QbD value comes from four main areas; (1) a reduction of Cost of Goods Sold (COGS) and capital expense, (2) increased technical development productivity, (3) improved quality and lower risk, and (4) increased sales.
I do not agree with items 1, 2 and 4 – the statements are questionable. But the most striking is the title: “The Scientist Is No Longer In The Laboratory”! I like this approach! Who will develop novel medicinal products? RA, QA or QC staff? Eroom law works well!

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