兽药GMP检查验收评定标准(新)232条.doc

兽药GMP检查验收评定标准(新)232条
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-文化程度并经本岗位技术培训。
* 007
从事原料药生产的人员应接受原料药生产特定操作的有关知识培训。
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist40
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
008
中药材、中药饮片验收人员应经相关知识的培训，并具有中药鉴别技能。
009
从事兽药生产辅助性工作的人员应具有初中以上文化程度并经本岗培训。
010
企业应年度的培训计划，明确培训的要求、方式和内容，并应根据实际情况调整培训内容。
011
进入洁净室（区）的工作人员（包括维修、辅助人员）应定期进行卫生和微生物学基础知识、洁净作业等方面的培训及考核。
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从事兽药生产的各类人员应按本规范要求和培训计划进行培训和考核；培训效果应达到要求，培训记录应归档。
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人员的现场考核结果应符合要求。
014
企业负责人应接受有关法律法规培训，提高法律意识和质量意识。
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist5
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
015
从事高生物活性、高毒性、强污染性、高致敏性及有特殊要求的兽药生产操作和质量检验人员应通过专业的技术培训后上岗。
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质量检验人员应具有高中（含中专）以上文化程度，并经相关知识培训，具有基础理论知识和实际操作技能，持有省级兽药监察机构核发的培训合格证。 质检人员的现场操作考核结果应符合要求。
017
质量部门负责人任命、变更应书面报省级兽药监察所（机构）备案。
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厂区周围不得有影响兽药质量的污染源；企业生产环境应整洁，其空气、场地、水质等应符合要求。厂区地面、路面及运输等不应对兽药生产造成污染；生产、仓贮、行政、生活和辅助区总体布局应合理