In recent blogs (1,2) I had discussed ways to financially justify QbD for the pharmaceuticals. However it is up to us (everyone involved with the development and manufacture of the pharmaceuticals) to carry out the task. Savings of similar magnitude are also suggested by McKinsey (3) and worth every effort.
The task is simple and we all have what it takes to go from “A” to “D”. Table 1 compares today’s methods to what is possible if we achieve “D”.
We can go from “A” to “D” through simple steps by breaking down each process step and task by asking why are we doing what we are doing. Success and improvement at each step will add up to give us the wins that are needed to have processes that are highly profitable, sustainable and give us the pride to be associated with. Once we get to “D” we would not be passing the inefficiency costs to the customers as we do today. We will improve profits and lower healthcare costs.
1. Financial Justification for QbD and Cost of Regulation Compliance http://pharmachemicalscoatings.blogspot.com/2012/05/financial-justification-for-qbd-and.html
2. Is Continuous Processing in Pharma’s Future? http://pharmachemicalscoatings.blogspot.com/2012/07/is-continuous-processing-in-pharmas_3850.html
3. Outpacing Change in Pharma Operations, December 2009, McKinsey & Co.
I believe that time for “QbD Spring” is here. Let us go and have some fun while doing it.