Giving industry what it wants
Industry has endless questions about QbD implementation, many of which boil down to convincing management to support and fund
the new risk-based science with the promise of regulatory and operational flexibility as a reward. What some may not understand,
however, says Basu, is that to achieve the full benefits of QbD, there must be a full implementation of QbD similar to what
other industries do.
"QbD implementation has to start early in process development. The product and process must be designed using sound scientific
principles." In addition, a company's manufacturing plant and systems must be capable of operating a QbD system.
"A well-designed process will not perform satisfactorily if the manufacturing plant does not have well-developed systems of
quality, effectiveness, performance, management, and continuous improvement," says Basu. Only then might companies experience
the estimated 25-30% savings in cost of goods sold for implementing QbD.
Industry also wants to know how its day-to-day work will change once QbD processes are in operation. "Today, if we want to
heat water in a tank, we do not need to develop a design space or validate that system. If we decide to heat acetone instead
of water, we do not need to revise our design space or submit lengthy change requests. This is because the science is available
to calculate how long it takes to heat water or acetone," explains Basu. "Our hope is that pharmaceutical science will reach
that level someday so that we can develop a manufacturing process in one step from laboratory data and then be able to predict
its performance with a high degree of accuracy to be able to control the process in the plant using sound manufacturing science
and ensure product quality without requiring FDA approval for every process change we make."
Basu says that petrochemicals is one industry that has successfully implemented science-and risk-based approaches into its
manufacturing processes. "Irrespective of the source of the crude oil, or the season, or the location of the refinery or gas
station, the quality of gasoline is always the same. We do not have to readjust our cars everyday or move our cars from one
place to the other," he explains. "There is a real need to invest in science and technology for our pharmaceutical process
development and manufacturing science. Pharmaceutical companies are trying to save manufacturing costs by outsourcing, but
QbD implementation can achieve much greater savings ... and help save our manufacturing jobs," he adds.
NIPTE is not conducting research simply to satisfy academic curiosity or to be published, says Basu. "Our research should
be useful to the regulators and industry to improve pharmaceutical product development and manufacturing. To this end, current
good manufacturing practices must be complemented by current good manufacturing technologies. However, this is a big challenge
for not only our industry and FDA, but also for academia in terms of working collaboratively with FDA, industry, foreign manufacturers,
and regulatory agencies to bring QbD wherever it maybe required to make overall improvement of the quality of our pharmaceutical
*Member universities include Duquesne University, the Illinois Institute of Technology, Rutgers University, Purdue University,
and the Universities of Puerto Rico, Connecticut, Iowa, Kansas, Kentucky, Maryland, and Minnesota.