Reducing costs and improving efficiency in manufacturing is critical. Efficient processes go hand in hand with processes that
are well understood. The focus on efficiency only occurs after processes are already stable, predictable and capable. The
issues associated with the availability of a critical product (e.g., flu vaccine) can have an extreme effect on the public.
If processes are better understood, and technology transfer could occur more smoothly, then shortage situations would occur
less frequently. Products that have efficient manufacturing processes typically are not the products that we fear will run
into problems related to market supply. In addition to these effects in manufacturing, reducing costs and speeding up product
development can enable important drugs to make it to market faster. The end game of continuous improvement is to improve costs
as well as to allow for faster innovation, deeper process understanding, and higher success rates of meeting the needs of
Everybody wants to improve; nobody wants to change. This lies at the heart of all improvements because, after all, improvement
is change. The management of this change is extremely important. The systems approach outlined in the quality system must
ensure confidence that correct decisions are being made and encourage science and risk based approach to these quality decisions.
They also promote process understanding, stressing the link between development and manufacturing, improving quality monitoring
and review (based on data methods such as process control and process capability) and encouraging preventive action over corrective
The pharmaceutical industry in many ways has been lagging behind many other industries in their adoption of these continuous
improvement activities. Having access to these approaches and having regulatory agencies in agreement on the rules of engagement
is the important first step.