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REVISED PROCESS VALIDATION GUIDELINE CLARIFIES "WORST CASE"

Executive Summary

REVISED PROCESS VALIDATION GUIDELINE CLARIFIES "WORST CASE" definition to emphasize that FDA is not asking manufacturers to stress a process to the failure point. "Worst case" is defined by the new draft to be "a set of conditions including those within standard operating procedures which pose a greater chance for process or product failure than ideal conditions." Such conditions, the new draft clarifies, "do not necessarily induce process or product failure." The newest draft of FDA's ongoing effort to establish process validation guidelines was released for review at a Device Good Manufacturing Practices (GMP) Advisory Committee meeting March 20. In highlighting changes in the current draft for the committee, Edward McDonnell, director of compliance at FDA's device center, noted that the concept of process validation as presented in the guideline "does not include stressing, testing a particular device or drug to the 'edge of failure,' as that term is used." Instead, in emphasizing the need for "worst case" testing, McDonnell noted, "we are talking about a manufacturer establishing confidence that the operating control limits established by the manufacturer . . . the so called tolerances, are fit to achieve their intended use. We would expect that a manufacturer would challenge his process to the extent possible by running it at the upper limits and making a judgment as to whether or not the product, the yield, was within acceptable specifications." Despite general agreement with the new definition of "worst case," both committee and industry spokesman at the meeting argued that the term "worst case" itself should be replaced due to confusion and emotional reaction stemming from its use in the past. Health Industry Manufacturers Association (HIMA) representative Jerry Jennings suggested that a phrase such as "best challenge relative to the standard operating procedures" would better describe "what we are really shooting for." Another change in the new draft is the inclusion of a section discussing the acceptibility of product testing in situations where drug products or medical devices are manufactured individually or on a one-time basis. Because the concept of prospective validation may have limited applicability in these situations, the guideline states, "the use of data obtained during the manufacturing and assembly process may be used in conjunction with product testing to demonstrate that the instant run yielded a finished product meeting all of its specifications and quality characteristics." However, FDA cautions, "such evaluation of data and product testing would be expected to be much more extensive than the usual situation where more reliance would be placed on prospective validation." McDonnell noted that the agency had chosen to employ the term "product testing" in place of "concurrent validation" in describing the limited run qualification process. Although paralleling the concept of "concurrent validation" as presented by industry proponents, McDonnell explained, the agency chose to employ the term "product testing," as it was felt to be "a more appropriate name for what is going on for the quality activity to assure reproducability of the process or to assure conformance to the design specification." Industry groups, including the Pharmaceutical Manufacturers Association, have stressed the importance of "concurrent validation" in qualifying the production of limited run products such as clinical supplies and orphan drugs.
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