新疆乳制品GMP认证

目  录颁布令···························································11主题内容和适用范围················································22引用标准···························································23术语和定义·························································34厂区环境····························································55厂房和车间·························································55.1厂房························································55.2安全设施·························································65.3屋顶与天花板·····················································65.4车间通风··························································65.5墙壁与门窗························································65.6地面与排水·······················································75.7 供水供汽设施····················································75.8照明设施···························································75.9洗手设施····························································85.10 较衣室···························································85.11仓库······························································86机械设备····························································86.1设计····························································86.2材质····························································96.3生产设备····························································96.4质量检验设备······················································97管理机构与人员······················································97.1管理机构····························································97.2人员要求···························································107.3教育培训···························································118卫生管理·························································118.1管理要求···························································118.2 厂区环境卫生管理·······················································118.3 厂房设施卫生管理 ····················································· 128.4 机械设备卫生管理·······················································128.5 辅助设施卫生管理·······················································138.6 清洗和消毒管·························································138.7 员工健康管理························································138.8 员工个人卫生管理·······················································138.9 除虫、灭害管理····················································148.10 污水管理························································148.11 工作服管理······················································148.12 有毒有害物管理························································149 生产过程管理·······················································159.1 生产操作规程的制订与执行···············································159.2 原材料··························································159.3 生产过程··························································1510 质量管理···························································1610.1 《HACCP管理手册》的制定与执行·········································1610.2 原辅料及包装材料的质量管理···········································1610.3 过程质量管理··················································1710.4 成品的质量管理························································1710.5 贮存与运输的管理······················································1710.6 成品售后管理·················································1810.7 记录管理·······················································1811 标签····························································1812 管理制度的建立和考核····················································1813 本手册的支持文件························································18申请人应提交的文件和资料 序号 GMP HACCP 1 认证申请书 2 法律地位证明文件复印件 3 有关法规要求的行政许可证复印件 4 生鲜乳日供应与企业日加工能力情况及大收奶区域半径的说明 5 生产管理、质量管理文件目录及GMP认证要求的相关文件 HACCP体系文件 6 组织机构图、职责说明和技术人员清单 7 厂区位置图、平面图、加工车间平面图、产品描述、产品工艺流程图及工艺说明 8 生产经营过程中执行的相关法律法规、标准和技术规范清单 9 产品执行标准目录（备案有效的企标） 10 主要生产和检验设备清单 11 近一年内质量监督、行业主管部门产品检验报告 12 承诺遵守相关法律法规、认证机构要求及提供资料真实性的自我声明 13 其他需要的文件一、乳制品企业GMP认证       1、 认证依据     认监委《乳制品生产企业良好生产规范（GMP）认证实施规则》规定：以GB12693-2003《乳制品企业良好生产规范》作为乳制品企业GMP的认证依据。     GB12693-2003《乳制品企业良好生产规范》是卫生部发布的全文强制性国家标准，所有乳制品生产企业必须遵守和达到其规定。标准规定了乳制品企业在原料采购、加工、包装及储运过程中，关于人员、建筑、设施、设备的设置以及卫生、生产和品质管理应达到的条件和要求。3 术语和定义    GB/T 15091—1994《食品工业基本术语》确立的以及下列术语和定义适用本规范。3.1 乳从哺乳动物中挤出的正常分泌物，**物且未从其中提取任何成分。3.2  乳制品    以乳及其制品为主要原料，利用全部或部分成分加工而成的液体、半固体或固体产品。如液体乳类、乳粉类、炼乳类、乳脂肪类、干酪类、乳冰淇淋类等。3.2.1 乳粉类    主要包括：全脂乳粉、脱脂乳粉、全脂加糖乳粉和调味乳粉、婴幼儿乳粉、其他配方乳粉。3.2.2 乳脂肪类    主要包括：稀奶油、奶油、无水奶油等。3.3 原材料    指原料、配料和包装材料。3.3.1 内包装材料    指与食品直接接触的食品容器，如瓶、罐、盒、袋等，及直接包裹或覆盖食品的包装材料，如箔、膜、纸、蜡纸等，其材质必须符合食品卫生标准。3.3.2外包装材料指不与食品直接接触的包装材料，包括标签、纸箱、捆包材料等。3.4产品    包括半成品、终半成品及成品。3.4.1半成品     指任何成品制造过程中的产品，经后续的制造过程，可制成成品。3.4.2 终半成品    指经过完整的加工过程但未包装标示完成的产品。3.4.3成品指经过完整的加工制造过程并包装标示完成的待销售产品。3.5厂房    指用于食品加工、制造、包装、贮存等或与其有关的全部或部分建筑及设施。3.5.1生产作业场所（车间）    指直接处理食品的区域。包括原材料预处理、加工制造、半成品贮存及成品包装等场所。3.5.1.1包装场所（车间）    指成品包装的场所，包括内包装室和外包装室。3.5.1.2内包装室    指进行与产品内容物直接接触的内包装作业场所。3.5.1.3外包装室    指进行不与产品内容物直接接触的外包装作业场所。3.5.1.4内包装材料准备室    指不必经任何清洗消毒程序即可直接使用的内包装材料，进行拆除外包装或成型等的作业场所。3.5.1.5 缓冲室    指原材料或半成品没有经过生产流程而直接进入管制作业区时，为避免管制作业区直接与外界相通，在入口处所设置的缓冲场所。3.6.2 作业区划分3.7.2.1清洁作业区    清洁度要求高的作业区域，如待包装的半成品贮存，充填及内包装车间等。3.6.2.2 准清洁作业区    清洁度要求**清洁作业区的作业区域，如原料预处理车间等。3.6.2.3 一般作业区    清洁度要求**准清洁作业区的作业区域，如收乳间、原料仓库、包装材料仓库、外包装车间及成品仓库等。3.7 辅助场所（车间）    指不直接处理食品的区域。包括检验室、原材料仓库、成品仓库、锅炉房、机修车间、较衣室、洗手消毒室、厕所和其它为生产服务的配套场所。

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