Manufacturers Encouraged to Enhance Clinical Relevance of Quality With QbD
This article was originally published in The Gold Sheet
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.
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Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.
"I went through several BLAs (biologics license applications) and these were randomly selected. … What is obvious is that in a typical BLA we do have a fairly wide range of parameters that are listed with ranges that are specified and these ranges are supported by data from clinical work, but more importantly from the validation runs that are done to support these parameters."