Back on July 17th, I related the results of a survey conducted by BioProcess Technology Consultants on industry attitudes toward QbD and its use (or expected use). The avowed attitudes seemed mixed and this seemed to stem from confusion at both the regulatory and user level.
The link above seems to suggest that the confusion stems from variable responses potential users have experienced with regulatory personnel. And not surprisingly, this could vary widely depending on the specific regulatory person/source. Many industry respondents felt the level of understanding at the reviewer level was variable and uneven. In other words, like most regulatory topics!
To QbD or not to QbD, that is the question
Whether tis nobler in the mind to suffer
The vagaries and confusion of FDA reviewers
Or to take arms with a massive CMC filing
To supplement QbD to avoid delays. And not to die,
Or lose precious time on the critical path to approval
To follow QbD -- perchance to gain flexibility with FDA
And cut manufacturing and regulatory costs
Or to suffer variable agency understanding and mixed response
That makes a calamity of one's pursuit and creates delay
For who would bear the percieved lack of risk assessment and justifications
But the applicants, and not the agency reviewers
Thus QbD uncertainty does make cowards of us all
Posted by Bruce Lehr Jul 26th 2012.