Thursday, August 30, 2012

Are The Savings of $120-$150 Billions Worth Having?


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”.


 QbAà
APPLICATION OF KNOWLEDGE,
CREATIVITY &
IMAGINATION
à  QbD

Pharmaceutical Processes
Today’s methods
Tomorrow’s (it will come) methods
Process Efficiencies
Less than optimum
Optimum
Process Technology
Old and expensive
Current and competitive
Product quality
Achieved through repeated analysis of intermediates and final product (QbA)
Minimum/no in-process analysis; final product should meet quality specs. (QbD)
Process Sustainability
Generally unsustainable
Sustainable
Regulatory compliance
Considerable effort needed and high cost. Citations high and expensive to remedy.
Should exceed regulatory guidelines at minimum cost. Minimum citations and easy to fix.  
Asset utilization
Poor, high capital investment.
Efficient and fast. Low capital investment.
Business Impact
Inventories: High
Response to Market: Slow
Product recalls: Bad Press and public relations.
Inventories: Low
Response to Market: High
Product recalls: Minimum to none.

                                                                        Table 1

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.

Girish Malhotra, PE

EPCOT International

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