Comments on: QbD in Theory and Practice http://blog.pharmtech.com/2011/08/15/qbd-in-theory-and-practice/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 By: Formulating Pharmacist http://blog.pharmtech.com/2011/08/15/qbd-in-theory-and-practice/comment-page-1/#comment-39792 Formulating Pharmacist Thu, 18 Aug 2011 13:00:09 +0000 http://blog.pharmtech.com/?p=4544#comment-39792 It is getting a little old llstening to those "not in the know" write about how slow industry is adopting QbD. What they may not realize is that QbD was "born" in industry in the early 1970's. Scientists @ Merck, like the late Joe Schwartz, were breaking ground by applying then new methods of DOE to understand their processes. Search the literature and you will also find scientific journal articles documenting the application of SPC to setting appropriate specs and being used to support a successful validation by showing minimal variability in a process. Although many report that there are financial benefits to using QbD, they have been elusive. Our industry is ultra conservative and if there was a cost savings it would have already been embraced. You don't need to be a black belt to do a literature search to see what industry has already accomplished without the fanfare of QbD. You don't need to be a financial wizard to know the difference in fictiion and fact when it comes to cost savings. So stop the whining about how slow industry is to adopt- you're only confirming your own ignorance. It is getting a little old llstening to those “not in the know” write about how slow industry is adopting QbD. What they may not realize is that QbD was “born” in industry in the early 1970’s. Scientists @ Merck, like the late Joe Schwartz, were breaking ground by applying then new methods of DOE to understand their processes. Search the literature and you will also find scientific journal articles documenting the application of SPC to setting appropriate specs and being used to support a successful validation by showing minimal variability in a process.

Although many report that there are financial benefits to using QbD, they have been elusive. Our industry is ultra conservative and if there was a cost savings it would have already been embraced.

You don’t need to be a black belt to do a literature search to see what industry has already accomplished without the fanfare of QbD. You don’t need to be a financial wizard to know the difference in fictiion and fact when it comes to cost savings.

So stop the whining about how slow industry is to adopt- you’re only confirming your own ignorance.

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