Tags: design space, Gerald Migliaccio
, risk mitigation, ROI
Pfizer's Gerald Migliaccio, Senior VP of Network Unit Performance, is an unabashed advocate for Quality by Design, and in a June 16 talk at DIA 2010 in Washington, DC, Migliaccio defended QbD against those who would say it is "too expensive" to implement. (This is a common refrain, particularly amongst smaller manufacturers who say "We're not Pfizer" and don't have the resources for QbD.) Migliaccio used ROI-related data from his own company's work to emphasize QbD's worth.
"Some people have said QbD is expensive, but there's a very large value proposition here," Migliaccio
"We have found that as you get more mature in QbD, you're doing a lot less non-value-added work around what is not critical.
added, "QbD and the risk assessments associated with it really allow you to focus on what's important."
There may be some incremental costs associated with initial implementation of QbD projects, Migliaccio
assented, but these are not as significant as many would believe.
said, these costs are only in drug development stages, "but those of us on the manufacturing side get the payback, so we have to play nice with each other."
shared an example of what he
first QbD product.
The Process Understanding Plan, or PUP, that the company devised contained seven development-related focus areas, 52 quality attributes, and 190 parameters.
What does this mean datawise?
"First of all, higher process capability," Migliaccio
For example, 81% of the company's traditionally developed drugs (i.e., not based on QbD principles) exhibited a process capability (Cpk) greater than 1.
"That's about 3 sigma," Migliaccio
cited another example in which Pfizer
compared deviations on three separate solid oral dose tablets, A, B, and C, with C being the company's QbD pilot drug.
For the full year 2007, 4-8% of product A lots had some form of deviation to be investigated.
For product B, the range was 0-1.5% (following continuous improvement efforts).
Product C, the QbD drug, measured 0.7% of batches with deviations, he
To end, Migliaccio
summarized what he
sees as the "QbD Value Proposition":
• process/product design-you're "lean by design," which results in cost savings
• process/product robustness-you reduce defects, rejections, investigations
• process control-"We're a little behind other companies in terms of real-time release, but trust me," Migliaccio
said, the benefit of QbD for control is real.
• regulatory flexibility
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