殺菌偏差中英ppt課件-展示頁(yè)
2025-05-09 22:57本頁(yè)面
【正文】 . EVALUATION BY A PROCESS AUTHORITYUNLESS THE EVALUATION DEMONSTRATES THAT THE PRODUCT HAD BEEN GIVEN A THERMAL PROCESS THAT RENDERED IT FREE OF MICROORGANISMS OF PUBLIC HEALTH SIGNIFICANCE – IT SHALL BE FULLY REPROCESSED OR DESTROYED. 記錄 21 CFR 一個(gè)一個(gè) 記錄應(yīng)記錄應(yīng) 由下列由下列 組組 成成 1. 偏差偏差2. 所用的所用的 評(píng)評(píng) 價(jià)程序價(jià)程序3. 結(jié)結(jié) 果果4. 采取的行采取的行 動(dòng)動(dòng) (處處 理理 )這項(xiàng)記錄這項(xiàng)記錄 必必 須須 被保留在被保留在 單單 獨(dú)的偏差獨(dú)的偏差 資資 料中料中 . RECORDS 21 CFR A RECORD SHALL BE MADE OF 1. THE DEVIATION2. EVALUATION PROCEDURES USED3. THE RESULTS4. THE ACTIONS TAKEN (Disposition)THIS RECORD MUST BE KEPT IN A SEPARATE DEVIATION FILE.最 終處 理經(jīng)過(guò) 全部的再 殺 菌或者主管當(dāng)局用 認(rèn) 可方法 證 明不存在公共健康危害 ……產(chǎn)產(chǎn) 品可以正常品可以正常 銷銷 售運(yùn)售運(yùn) 輸輸 .否否 則產(chǎn)則產(chǎn) 品必品必 須銷須銷 毀毀 .FINAL DISPOSTIONAFTER FULL REPROCESSING OR A DETERMINATION THAT NO PUBLIC HEALTH HAZARD EXISTS BY A COMPETENT PROCESSING AUTHORITY USING RECOGNIZED PROCEDURES……THE PRODUCT MAY BE SHIPPED IN NORMAL DISTRIBUTION.IF NOT, THE PRODUCT MUST BE DESTROYED.21 CFR 21 CFR 指 導(dǎo) 的酸化食品偏差A(yù)CIDIFIED FOODS (AF) DEVIATIONSGOVERNED BY 21 CFR 21 CFR 21 CFR 定的酸化食品偏差是什么？1 與 預(yù) 定 殺 菌 規(guī) 程的偏差以及以及 /或者或者2 終產(chǎn) 品平衡 pH高于 WHAT IS AN ACIDIFIED FOODS DEVIATION UNDER 21 CFR ?1 DEVIATION FROM THE SCHEDULED PROCESSAND/OR2 THE EQUILBRIUM PH OF THE FINISHED PRODUCT IS HIGHER THAN 偏差的 補(bǔ) 救方法是什么？1. 完全重新 殺 菌 – 使用 殺 菌主管當(dāng)局建立的 殺 菌工藝 足以保 證產(chǎn) 品的安全 或者或者2. 在 21 CFR 113 指 導(dǎo) 下按照低酸食品 進(jìn) 行 熱殺 菌 (從開(kāi)始就必 須滿 足 Part 113的所有要求 ) 或者或者3. 留下 產(chǎn) 品做公共健康 評(píng) 價(jià)WHAT IS THE REMEDY FOR A DEVIATION?1. FULLY REPROCESS – USING A PROCESS ESTABLISHED BY A PROCESS AUTHORITY AS ADEQUATE TO ENSURE A SAFE PRODUCT OR2. THERMALLY PROCESS IT AS A LOWACID FOOD UNDER 21 CFR 113 (Starting ove
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