Despite the fanfare, guidance documents from ICH and the world’s regulatory agencies, a plethora of conferences, much discussion on various social media sites and a good number of examples for QbD implementation, there is little published about where industry really stands with regards to adopting and implementing QbD.

So, it was very interesting to read the FDA’s more robust stance for full implementation of QbD, by the generic pharmaceutical industry, when filing an abbreviated new drug application (ANDA).  As the much anticipated January 2013 deadline looms, is the generic pharmaceutical industry prepared?  Only they themselves can answer that question, but the industries which support this community and in return are supported by the pharmaceutical sector, must also be prepared.

The analytical instrument development and manufacturing community is an important piece of this QbD puzzle.  Process Analytical Technology (PAT) does not equal QbD, this is well understood and stated all too often, but let’s face it, at the very core of QbD is the need to measure; to make timely measurements.

So, here are questions to all of those involved in pharmaceutical QbD.

  • Are analytical instrument developers on the same page with respect to providing the appropriate measurement tools?
  • What defines the best analytical measurement technologies supporting QbD? 
  • Is it the ability to measure within the process or simply take the measurement technology to the sample? Or are laboratory based technologies still sufficient? 
  • Are the best technologies non-invasive, non-destructive or are these attributes of no consequence? 
  • Does measurement and analysis need to be quick; seconds rather than hours?

Must the technology be developed and maintained with a demonstrable life-cycle approach.  I would be very interested to hear your thoughts.