内蒙古乳制品GMP认证
  • 内蒙古乳制品GMP认证
  • 内蒙古乳制品GMP认证
  • 内蒙古乳制品GMP认证

产品描述

目 录
颁布令···························································1
1主题内容和适用范围················································2
2引用标准···························································2
3术语和定义·························································3
4厂区环境····························································5
5厂房和车间·························································5
5.1厂房························································5
5.2安全设施·························································6
5.3屋顶与天花板·····················································6
5.4车间通风··························································6
5.5墙壁与门窗························································6
5.6地面与排水·······················································7
5.7 供水供汽设施····················································7
5.8照明设施···························································7
5.9洗手设施····························································8
5.10 更衣室···························································8
5.11仓库······························································8
6机械设备····························································8
6.1设计····························································8
6.2材质····························································9
6.3生产设备····························································9
6.4质量检验设备······················································9
7管理机构与人员······················································9
7.1管理机构····························································9
7.2人员要求···························································10
7.3教育培训···························································11
8卫生管理·························································11
8.1管理要求···························································11
8.2 厂区环境卫生管理·······················································11
8.3 厂房设施卫生管理 ····················································· 12
8.4 机械设备卫生管理·······················································12
8.5 辅助设施卫生管理·······················································13
8.6 清洗和消毒管·························································13
8.7 员工健康管理························································13
8.8 员工个人卫生管理·······················································13
8.9 除虫、灭害管理····················································14
8.10 污水管理························································14
8.11 工作服管理······················································14
8.12 有毒有害物管理························································14
9 生产过程管理·······················································15
9.1 生产操作规程的制订与执行···············································15
9.2 原材料··························································15
9.3 生产过程··························································15
10 质量管理···························································16
10.1 《HACCP管理手册》的制定与执行·········································16
10.2 原辅料及包装材料的质量管理···········································16
10.3 过程质量管理··················································17
10.4 成品的质量管理························································17
10.5 贮存与运输的管理······················································17
10.6 成品售后管理·················································18
10.7 记录管理·······················································18
11 标签····························································18
12 管理制度的建立和考核····················································18
13 本手册的支持文件························································18
内蒙古乳制品GMP认证
(2) 审核实施
★ 认证审核:为一阶段现场进行,现场审核应安排在认证范围覆盖产品的生产期,审核组应在现场观察产品的生产活动。现场审核发现的不符合项,受审核方应在3个月内完成整改并申请现场验证,涉及专业的不符合项由专业审核员完成。如受审核方未能在3个月内完成整改或未通过验证的,认证活动终止。
★ 跟踪审核:认证机构至少每年度对获证企业进行2次监审,其中至少1次为不通知监督审核(审核前48小时内提供审核计划)。首次监审应在初次认证后6个月内实施。获证企业次不接受审核将进行书面告诫,第二次不接受审核将导致证书暂停。
★ 再认证:认证证书有效期满前3个月,可申请再认证。再认证程序与初次认证程序一致。
内蒙古乳制品GMP认证
2、 认证申请人资格
申请乳制品GMP认证的企业必须具备有效的企业法人资格,且取得相关法规规定的行政许可文件;产品符合国家《标准化法》等国家相关法律法规、食品安全标准和有关技术规范要求;必须在厂区环境、厂房车间设施、设备、机构与人员、卫生管理、生产过程管理、品质管理以及标识等8个方面按照GB12693-2003建立和实施GMP;产品生产工艺定型并持续稳定生产。申请人需提交的文件和资料详见附表1。
3、 认证审核
认证审核将依据GB12693-2003标准,通过文件审核和现场验证,全面、系统地对上述8各方面进行评价,以确定企业是否能够通过认证,获得乳制品GMP证书。
内蒙古乳制品GMP认证
3、生产设备:
①设计:所有机械设备的设计和构造要有利于保证食品卫生,易于清洗消毒,并容易检查。要有使用时可避免润滑油、金属碎屑、污水或其他可能引起污染的物质混入食品的构造。食品接触面要平滑、无凹陷或裂缝,以减少食品碎屑、污垢及有机物的聚积,使微生物的生长减至低程度。设计要简单,且为易排水、易于保持干燥的构造。储存、运输及加工系统(包括重力、气动、密闭及自动系统)的设计与制造要易于使其维持良好的卫生状况。在食品加工或处理区,不与食品接触的设备与用具,其构造要也能易于保持清洁状态。 工厂内的所有物料贮存设备,如贮奶缸、配料缸等均要装有顶盖,生产和原料包装材料贮存区以外要有指定的存放设备备件的备品架,并易于保持清洁干燥,以便各种工具使用后能及时放回指定位置。清洗消毒设备和乳管路宜采用就地清洗(CIP)系统。
②材质:所有用于食品处理区及可能接触食品的设备与用具,要由无毒、无臭味或异味、非吸收性、耐腐蚀且可承受重复清洗和消毒的材料制造,同时能否避免使用会发生接触腐蚀的不当材料。 产品接触面不可使用木质材料。
③生产设备:排列要有序,使生产作业顺畅进行并避免引起交叉污染,而各个设备的能力要能相互配合。用于测定、控制或记录的测量器和记录仪,要能充分发挥其功能且必须准确,并定期校正。用于食品、清洁食品接触面或设备的压缩空气或其他气体要经过滤净化处理,以防止造成间接污染。 收乳及储乳设备要包括计量设备、乳桶和奶槽车等贮乳设备及洗涤杀菌设备、过滤器或净乳机、冷却设备、有绝热层的储乳罐、原料乳检验设备、制冷设备等。预处理设备要包括混合调配设备(原料调配罐、标准化调配罐)、均质机、过滤器或净乳机、热交换器(杀菌器)等。鲜乳及再制乳加工设备要包括预处理设备、乳液储存设备、洗瓶机及装瓶机(限于玻璃瓶)或自动纸器包装机或塑料薄膜包装机、日期打(喷)印机、清洗设备、成品冷藏库等。发酵乳加工设备要包括预处理设备、菌种培养设备、搅拌器(混合机)、发酵液储存罐、发酵液稀释罐、洗瓶机(限于玻璃瓶)、检瓶机(限于玻璃瓶)、灌装机、日期打(喷)印机、培养室、冷藏库等。炼乳加工设备要包括预处理设备、浓缩设备、空罐清洗消毒设备、包装机、高压灭菌机、冷却设备、结晶设备(甜炼乳)等。 乳粉加工设备要包括预处理设备、浓缩设备、喷雾干燥系统、粉体冷却设备(流化床)、筛粉机、乳粉储槽或粉仓-贮粉设备、添加物混合设备、空罐杀菌机、乳粉包装机等。奶油加工设备要包括原料乳储罐、奶油分离机、杀菌机、稀奶油储罐、酪乳储罐、奶油泵、奶油包装机以及根据实际生产增加相应设备,如稀奶油成熟罐、连续奶油加工机等。干酪生产设备要包括预处理设备、干酪槽或凝乳槽、干酪盐水槽、压滤槽车、干酪加热成型机、发酵室、熔化锅、切割机、包装机等。 CIP设备要包括清洗液储罐、喷洗头、清洗液输送泵及管路管件、程序控制装置等。其他乳制品的加工要有必要的专业生产设备。
④供水站:要由中专以上并经培训考核合格的专业人员进行专职管理。要制定详细的操作规程及管理制度,要有严格系统的水质检验、系统维修与保养记录,主管人员要定期检查考核,至少每季度1次。所有设备要经常维修保养,保持良好卫生状况,使用的工具必须符合卫生要求,消毒剂等必须妥善贮藏,严格登记使用,帐物相符;其它与水质处理无关的杂物不得放置在站内。要对贮水槽(塔、池)定期(至少每季度1次)清洗、消毒;并随时检查水质,确保生产用水的水质符合GB5749的规定。闲杂人员不得入内;平时各种检修口、门窗必须盖好、关好(防止投毒)。
⑤锅炉房:锅炉操作人员上岗前必须经过培训,考核合格后上岗。必须严格按劳动部门的要求对锅炉进行安全操作与维修、保养。用于炉内水处理的药品要无毒并严格控制使用量,定期排污(有排污记录),以防止蒸汽品质劣化。必须对锅炉排烟进行监控,其排放要符合GB13271的规定。对排烟管道等定期进行清理,防止对厂区环境造成的污染。锅炉用水若采用化学方法除氧、除硬,则应注意脱氧剂、清垢剂对蒸汽品质的影响,以防终导致食品污染。
⑥污水、污物管理:污水排放要符合GB8978的要求,不符合标准者要采取净化措施,达标后排放。污物管理要按GB14881中5.8.2执行。厂区设置的污物收集设施,要为密闭式或带盖,要定期清洗、消毒,污物不得外溢,要于24小时之内运出厂区处理。做到日产日清,防止有害动物集聚孽生(GB14881)。
4、品质管理设备:企业必备的出厂检验设备
⑴分析天平(精度为0.1mg)
⑵干燥箱(恒温干燥箱)
⑶离心机(符合GB/T5413要求)
⑷杂质度过滤机(符合GB/T5413要求)
⑸不溶度指数搅拌机(符合GB/T5413要求)
⑹蛋白质测定装置(凯氏定氮仪或自动蛋白质测定仪)
⑺干燥灭菌器(高温干燥箱)
⑻湿度灭菌器(高温杀菌釜)
⑼水浴锅(恒温水浴锅)
⑽生物培养箱(恒温培养箱)
⑾分光光度计——硝酸盐、亚硝酸盐检验用
⑿生物显微镜
⒀无菌室或超净工作台
⒁荧光PCR仪(符合SN/T1632.3方法要求)——阪崎肠杆菌检验用
⒂高速离心机(符合SN/T1632.3方法要求)——阪崎肠杆菌检验用
⒃高温灰化炉
5、人员:食品检验人员为大专以上相关专业学历,或者中专学校毕业从事食品检验工作两年以上或经省级以上(包括省级)行政主管部门认可的权威技术部门专业培训后取得相关专业检验资格者。工厂要有足够的品质管理及检验人员,能做到每批产品检验。专职卫生管理人员要具备卫生或相关专业大专以上学历或同等学厉;兼职卫生管理人员要具备卫生或相关专业中专以上学历或同等学历。生产管理、品质管理、卫生管理负责人要具备大专以上相关专业学历或中专相关专业学历并具备4年以上直接或相关管理经验。
6、现场产品抽样检验合格。
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