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.
- Financial Justification
for QbD and Cost of Regulation Compliance http://pharmachemicalscoatings.blogspot.com/2012/05/financial-justification-for-qbd-and.html
- Is Continuous Processing in Pharma’s Future? http://pharmachemicalscoatings.blogspot.com/2012/07/is-continuous-processing-in-pharmas_3850.html
- 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
