Maybe not a buzz word, but apparently not embraced if the results of this survey are taken at face value. In this bioPULSE survey, 80% of industry respondents said they have used QbD methods at least once, and only 5% say it is worthless, but............only 29% say it is used routinely in their job in biopharmaceutical development. Only 3% in tech transfer jobs reported using it (though that may reflect low participation by tech transfer functions in this survey)
Lack of training may be one reason for low use. Many respondents (20%) believe that use of QbD will delay regulatory filings and 15% actually believe it will delay approvals. If the FDA isn't an advocate of using QbD who is? Only 26% of respondents believe use of QbD will expedite approvals.
The survey conductors believe that many respondents don't fully understand what QbD is. Perhaps, even more educational efforts are needed toward what QbD means to biopharm development and how it can help.
Posted by Bruce Lehr Jul 17th 2012.