MAKING THE BUSINESS CASE
Those who are on board with QbD as a way to achieve reduced process variability may need help getting management to buy into
this idea in their companies by putting together a convincing business case. New initiatives and related technology at pharmaceutical
companies usually are evaluated by decision makers and their influencers, based on how well they do the following:
- apply to existing priorities
- leverage existing investments
- have a clear project definition and scope
- offer near-term return to the bottom-line
- make a significant impact on corporate goals.5
Relating a QbD initiative to these criteria can help highlight the business benefits and gain management buy-in. As we have
seen, significant business and quality compliance benefits can be achieved through QbD when process development and manufacturing
teams collaborate. But to achieve these benefits, the right enabling technologies are also required.
1. Application to existing priorities
It is advantageous to align QbD with existing corporate priorities. Initiatives can be tied to two overarching themes that
are likely to be high up on companies' priority lists because they are essential for staying in business, given the regulatory
and competitive pressures that exist today: 1) operating in the public's best interest through regulatory compliance and 2)
remaining competitive for the long-term in the marketplace.
If there is not a clear common thread between QbD and existing corporate priorities, perhaps it is more prudent to first make
a case for adjusting corporate priorities to take the current regulatory environment and the company's long-term competitiveness
more fully into account.
2. Leveraging existing investments
Particularly in terms of information technology (IT) investments, it is important to demonstrate how process development and
manufacturing teams can easily access and get added value out of data in existing systems, such as laboratory information
management systems (LIMS), paper records, enterprise resource planning (ERP), manufacturing execution systems (MES), and in
some cases, electronic batch record (EBR) systems. This is an important factor to IT decision makers, as well as CFOs, who
may be evaluating the merits of QbD initiatives.
A strong argument to use is reversing the Pareto Principal, also known as the 80/20 rule. This rule was popularized by the
late Juran, who observed that 80% of effects come from 20% of causes. Juran named this principle after Italian economist Vilfredo
Pareto, who observed that 80% of income in Italy went to 20% of the population. In the pharmaceutical industry, if 80% of
time is typically spent trying to access the necessary data and only 20% of time is spent analyzing data to understand and
control the cause of process variability, there is a clear business reason for reversing those percentages. Easy, on-demand
access to all types of data provided in appropriate context for users' needs is the best way to reverse the 80/20 rule.
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