A Simple Equation

12/01/2004

a = contamination control expertise

Whether your expertise is in facility or equipment design, delivery systems, process control, materials science or test and analysis, contamination control is a core element of your knowledge base. And, it is this common thread that allows your expertise and experience to transcend the boundaries of individual product production and, in fact, the boundaries of otherwise unrelated industries.

b = manufacturing science initiative

More than any other single factor, the inability of the bio/pharmaceutical industry to streamline its drug development and introduction process and/or to predictably and safely improve the yield of its manufacturing processes is the direct result of inadequate understanding of its process science and its inability or unwillingness to share what knowledge it does have with the agency responsible for ensuring product safety, i.e., the FDA.

a + b = an unprecedented opportunity for, and a challenge to, the contamination control community

At last month's meeting of the American Association of Pharmaceutical Scientists (AAPS), FDA's Director of the Office of New Drug Chemistry (ONDC), Moheb Nasr, PhD, could not have been more clear in his message to industry. Referencing "ONDC's New Risk-based Pharmaceutical Quality Assessment System" document, Nasr says it is "a lack of process understanding and insufficient product knowledge information in applications that has lead to tight product specifications at the time of approval, resulting in unnecessary recalls and drug shortages if a product batch fails to meet the specification."

The recognition of this fact, in conjunction with the FDA's overall new "Risk-based Approach to cGMPs" initiative, has already lead to major organizational restructuring within the FDA. Among the most significant of these moves is the creation of the new Pharmaceutical Quality Council and, in particular, the Manufacturing Science Branch within ONDC. The new branch reflects the guiding principle that manufacturing science will be an integral part of the new quality assessment system. And, in case anyone has not yet noticed, the document also specifically states that facility inspection will be incorporated into quality assessment as well.

But, while the FDA is aggressively encouraging the manufacturing science research and reporting work needed by the bio/pharmaceutical industry, it is nonetheless industry that must respond to the call. As noted by Dr. Nasr, "Continuous improvement of the manufacturing process, including process understanding and control issues, are the industry's responsibility, not the Agency's. We need to be aware of these process control strategies as a review function."

The bottom line is that hard process and manufacturing science is now the top dog on the FDA's team, and nobody understands this science better than contamination control professionals. Without having first thoroughly examined, analyzed and understood every detail of the semiconductor manufacturing process, the contamination control systems and practices in place today would not have been possible. Contamination control experts recognize that, regardless of the technology being produced, a complete understanding of the process science employed is a prerequisite to effective, efficient and reliable contamination control, and with it high-yield production.

Clearly, the contamination control community should take the industry lead in endorsing the science-based manufacturing initiative being put forward by FDA. And, contamination control experts from multiple industries and multiple disciplines should begin as soon as possible to plan and form the necessary working groups to coordinate and expedite the effort.

Wherever or however this takes place is not important, but—though it may be a shameless plug, I think it's also a reasonable suggestion—the CleanRooms Contamination Control Technology (CCT) conference in Boston, March 22-23, might be a good place to get started. We're certainly ready to provide any support we can to any such initiatives.
JSH