杀菌偏差中英文).pptVIP

IF YOU SET ASIDE THE PRODUCT FOR AN EVALUATION THE EVALUATION SHALL BE MADE BY A COMPETENT PROCESS AUTHORITY AND 2. SHALL BE IN ACCORDANCE WITH PROCEDURES RECOGNIZED BY COMPETENT PROCESS AUTHORITIES AS BEING ADEQUATE TO DETECT ANY POTENTIAL HAZARD TO PUBLIC HEALTH. 如果留下产品做公共健康评价 除非评价证明食品经过了使之安全的杀菌, 留下的食品将: 1. 完全重新杀菌使之安全 或者 2. 销毁 IF YOU SET ASIDE THE PRODUCT FOR AN EVALUATION UNLESS THE EVALUATION DEMONSTRATES THAT THE FOOD HAS UNDERGONE A PROCESS THAT HAS RENDERED IT SAFE, THE FOOD SET ASIDE SHALL BE: 1. FULLY REPROCESSED TO RENDER IT SAFE OR 2. DESTROYED 21 CFR 114.89 and 114.100记录 记录应由以下组成: 1. 偏差 2. 识别出的产品受影响的部分 3. 使用的评价程序 4. 结果以及 5. 最终采取的行动 (处理). 记录必须保留在一套独立的偏差文件中. RECORDS 21 CFR 114.89 and 114.100 A RECORD SHALL BE MADE OF: 1. THE DEVIATION 2. THE EFFECTED PORTION OF THE PRODUCT IDENTIFIED 3. EVALUATION PROCEDURES USED 4. THE RESULTS AND 5. THE FINAL ACTION TAKEN (Diposition). THIS RECORD MUST BE KEPT IN A SEPARATE DEVIATION FILE. 最终处理 经过全部的再杀菌或者主管当局用认可方法证明不存在公共健康危害 …… 产品可以正常销售运输. 否则产品必须销毁. FINAL DISPOSTION AFTER 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. 当你遇到偏差时你还能够做什么? 108.35(d)当偏差本质存在潜在公共健康显著性危害，且这种食品任一批次已经整体或部分进入商业销售时，受雇于低酸密封包装食品热杀菌工艺的商业杀菌员应该迅速向FDA汇报任何腐败例证或者杀菌偏差。 SO WHAT ELSE DO YOU DO WHEN YOU HAVE A DEVIATION? 108.35(d) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any instance of spoilage or process deviation the nature of which indicates potential health significance, where any lot of such food has in whole or in part entered distribution in commerce. 当你遇到偏差时你还能够做什么? 108.35(e)当其中任一批次受微生物污染可能危及健康的该产品已经整体或部分进入销售时.受雇于低酸密封包装食品热杀菌工艺的商业杀菌员应该迅速向FDA汇报任何事例。 SO WHAT ELSE DO YOU DO WHEN YOU HAVE A DEVIATIO