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This includes: Product release decisions Sterility assurance Environmental monitoring Laboratory testing Stability programs Batch disposition Once confidence in data is lost, FDA must assume that the entire quality system may be compromised

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Tobacco Use Prevention Education (TUPE) TUPE: Tobacco Use Prevention Education Program The purpose of the TUPE program is to reduce youth tobacco use by helping young people make healthful tobacco-related decisions through tobacco-specific, research-validated educational instruction and activities that build knowledge as well as social skills and youth development assets