FDA, USP<1116>, HACCP, ISO/TC209 = Contamination Control

FDA, USP<1116>, HACCP, ISO/TC209 = Contamination Control

John Haystead, Editor-in-Chief

An inevitable problem arises whenever a new technology is adopted by multiple industries and nations. It is simply that each group never implements the technology in exactly the same way. The science is also often not referenced and documented using the same units of measure and nomenclature, and, most importantly, protocols and procedures relative to the best way to use the technology are almost always hotly contested. In other words, there are no common standards.

One recent case in point is the United States Pharmacopeia`s (USP`s) proposed chapter <1116> on “Microbiological Evaluation of Cleanrooms and Other Controlled Environments” which is under review.

Despite the fact that “information chapters” such as USP<1116> are theoretically intended to provide only advice and guidance, the common industry perception is that many FDA inspectors treat them as requirements as well. In fact, many in the pharmaceutical industry perceive that the FDA uses USP guidelines to implement regulations it would otherwise have difficulty officially mandating.

Whether or not this perception is completely accurate, however, there`s no question that the outcome of the USP`s chapter on cleanrooms will have a tremendous impact on the practices of the pharmaceutical industry.

At the same time, the Institute of Environmental Sciences is also addressing microbiological contamination through its work on behalf of ISO/TC-209. Working Group 2 (WG02) is specifically addressing this area aiming ultimately at developing a set of international contamination control standards. Although ISO standards are themselves voluntary in the U.S., they will also certainly factor heavily into any FDA quality-conformance evaluations.

Another point to consider is that contamination control standards and practices are far from industry specific. For example, at least one of the practices currently being reviewed for use in the pharmaceutical industry actually originated in the food industry segment of the FDA. Subsequently embraced by the European aseptic community, the Hazard Analysis and Critical Control Point (HACCP) concept now appears to be coming full circle, at least in some form, to impact practices in the parenteral drug industry.

Industry and academia have already recognized that contamination control technology encompasses a wide and growing number of industries, yet the U.S. government`s current list of regulatory agencies and their respective sub-divisions are still working largely in isolation from each other. It may be time for the FDA, for one, to do more to address contamination control technology from a common baseline perspective, at least with regard to the many industries it monitors. Encouraging a multi-industry view of contamination control will not only help eliminate some of the confusion regarding mandated vs. suggested practices, it will also help stimulate technology development and the cross-flow of ideas across industry and international boundaries.


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