Laura Bush
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Last month, the Food and Drug Administration finalized its quality systems guidance. The document describes a holistic way
of looking at quality: it lays out five broad systems that fall under a sixth overall system, all of which work together to
ensure that no product that is out-of-specifications is released.
The guidance links these broad concepts to the detailed rules contained in the good manufacturing practices regulations. Another
new guidance, on how to handle out-of-specification test results, addresses a key aspect of quality control in more detail.
A third new guidance, from CBER, also takes a systems approach to quality. Philip Krause, Deputy Director of the Division
of Viral Products of the Office of Vaccines, comments that the guidance on characterizing cell substrates for viral vaccine
manufacturing doesn't contain anything new. Rather, it consolidates long-standing methods and recommendations on the testing
for adventitious agents, endogenous viruses, and related risks. Most importantly says, Krause, it was written as a principles-based
document; by explaining the scientific rationale behind the concepts, the agency hopes the document will provide manufacturers
with a platform for evaluating new technologies. In other words, it is a type of quality system.
These developments come at a time when an emerging field, nanotechnology, has been receiving a lot of attention. Over recent
weeks, one declaration after another appeared in the industry news. Michael Taylor of the Project of Emerging Nanotechnologies
issued a report saying that FDA has neither sufficient resources nor authority to regulate nanotechnology properly. The NanoBusiness
Alliance countered that although financial and human resources are an issue, authority is not. The concern about resources
was supported by a report by the National Research Council, which said that federal agencies should provide more funding to
study the environmental, health, and safety risks that nanotechnology presents. FDA then consulted its Advisory Committee
on Pharmaceutical Science. The committee recommended that the agency approach new nanotechnology products much the way it
handles new drug applications, requiring that the sponsor submit complete data to support the indication, safety, and efficacy
of its product. The committee also recommended that the agency broaden its definition of nanotechnology, to include a broader
range of products.
What all this discussion is about, really, is the need for a quality system for nanotechnology. We must define the parameters
of it, determine if FDA has the authority and resources it needs to regulate it, and then develop a set of rules for how the
agency will evaluate products using nanotechnology.
Interestingly, one of this year's Nobel prizes was essentially for a quality system. The award for physiology or medicine
went to Andrew F. Zire and Craig C. Mellos for their 1998 discovery of how genes are controlled within living cells through
gene silencing, or RNA interference. What Zire and Mellos discovered—with the support of colleagues as well as scientists
in other fields—is that the cell has a system for ensuring that "out-of-specification product," such as viral genetic material
or the proteins it encodes for, is not produced. The cell uses fragments of double-stranded RNA to identify viral RNA for
destruction; in a similar way, the cell uses this function to control the expression of its own genes, to ensure that the
right activity occurs at the right time—keeping everything in spec, so to speak.
Thus, it seems that in developing quality systems for manufacturing drugs, producing vaccines, or regulating new technology,
we are following the example of our own cells.
I guess you could say that quality systems are in our genes.
Laura Bush is the editor in Chief of BioPharm International,
lbush@advanstar.com
