Out-of-spec, system suitability lab practices seminars to be held by FDA, industry.
Executive Summary
OUT-OF-SPEC/LAB FAILURES WILL BE SUBJECT OF UPCOMING FDA, INDUSTRY SEMINAR called to address problems related to laboratory aspects of the development and monitoring of pharmaceuticals. FDA will issue a Federal Register notice to announce the seminars, which are expected to convene in the first quarter of 1997. The discussions would operate as a pilot project, and a comment mechanism will be established.