保健食品生产企业良好生产规范审查申请须知

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1、promote the extension of strictly administering the party grass-roots, but also the educational practice of the mass line of the party and three-three special education results achieved further inherited and expanded. To realize two a learning education is a necessary solution to the present problem

2、s of party construction. Strengthen problem consciousness and insisted on problem-oriented, is full of strictly administering the party since the partys 18 a distinctive feature, a successful experience. Secretary Wang noted that some party members still have political awareness, lack of political r

3、esponsibility issues, party awareness and consciousness of the problem belief does not really believe, slim does not actually fix problems, outspoken, and jump on the assessment of the partys policies, and so on. Bi Lifu Secretary pointed out that a quarter of the economic situation is very serious,

4、 there is pressure on environment, seasonal factors and other objective reasons, but mainly subjective problem, is the problem of party members and cadres. Some depressed, negative slack, not responsible, . Double six, one, and two took the lead, build energy burst, Hongshan district, economic prosp

5、erity, eco-livable, civilized and harmonious island. It certainly can not be separated from the whole area 646 grass-roots party organizations and 14,146 members of broad participation and support. Through the two study and education, so that every cell of the party health, every organization is str

6、ong, so that all members of the vanguard and exemplary role, all the fighting bastion role of grass-roots party organizations into full play so that we can cross the Rapids, overcome all difficulties and the smooth realization of the Thirteen-Five goal. Second, basic learning, focus on learning educ

7、ation must understand the learning content and learning styles Foundation learning these four words are important information inside is very large, capture profound work truth in life. For example, I often say that the good Carpenter NAO Carpenter, why do some carpenters made furniture to have every

8、body likes it, Carpenter we are not willing to look for him? are apparently two people high and low technology, dig into the deep is firmer when both of his apprentices are not solid, there is no good that way. Luban art of story primary school are learn had, first after six mark test practice condu

9、ct, and practice cultivation, and practice perseverance, and practice patience, then with seven days seven night mill axe theory armed, and unity action, seriously learning XI General Secretary on reform development stable, and Interior diplomatic defense, and rule party ruling army of important tho

10、ught, seriously learning to XI comrade for General Secretary of Central ruling acting political new concept new thought new strategy, seriously learning XI General Secretary study in Inner Mongolia important speech spirit, Guide party members and a deep understanding of a series of important speeche

11、s rich connotation and core ideas, which began so thoroughly Marxist positions保健食品生产企业良好生产规范审查申请须知项目名称：保健食品生产企业良好生产规范审查申请 法定实施主体：重庆市食品药品监督管理局 依据： 1.保健食品注册管理办法（试行）（国家食品药品监督管理局令第19号）； 2.保健食品良好生产规范； 3.卫生部关于印发保健食品良好生产规范审查方案与评价细则的通知（卫法监发200377号）。 收费标准：不收费 期限： 自受理之日起，15个工作日内完成资料审查，10个工作日内完成现场审查，5个工作日内做出审查

12、结论。申请人补正资料和整改所需时间不包括在内。 程序 一、申请与接收： 申请人需提交以下资料： 1.保健食品GMP审查申请表；2.保健食品生产管理和自查情况；3.企业的管理结构图；4.营业执照、保健食品批准证书的复印件（新建厂无需提供）；5.各剂型主要产品的配方、生产工艺和质量标准，工艺流程图； 6.企业专职技术人员情况介绍；7.企业生产的产品及生产设备目录；8.企业总平面图及各生产车间布局平面图（包括人流、物流图，洁净区域划分图，净化空气流程图等）；9.检验室人员、设施、设备情况介绍；10.质量保证体系（包括企业生产管理、质量管理文件目录）；11.洁净区域技术参数报告（洁净度、压差、温湿度等

13、）； 12.主要审查范围所涉及品种的试生产产品的检测报告（新开办的保健食品生产企业）； 13.国家食品药品监督管理局及市食品药品监督管理部门认为有必要提供的其他资料。 申请资料要求： 1.纸质申请书一式二份，其它资料一份； 2.所附的资料均须采用A4纸打印并逐页加盖公章或骑缝章，图纸需标明面积及尺寸； 3.申请书附电子文档。 工作标准： 1.确定本次申请的项目是否属于本部门职权范围； 2.申请材料应完整、清晰，要求签字的须签字，每份申请材料加盖企业公章；使用A4纸打印或复印，装订成册； 3.核对申请材料中同一项目的填写是否一致，提供的复印件是否与原件一致、是否清晰； 4.核对申请资料与申请书上

14、所选的附加资料目录是否一致，核对申请书上自我申明栏是否签字盖章； 5.对申请材料进行形式审查，保证申请材料的完整性.准确性和一致性，对已接收的申请应上网公告。 岗位责任人： 受理中心工作人员 岗位职责及权限： 1.受理中心接收资料人员按所需资料目录清点申请资料，申请资料齐全的，发申请资料签收单； 2.按照形式意见审查表查验申请材料； 3.对申请材料齐全、符合形式审查要求的，应及时接收，填写受理通知书，受理中心将受理通知书交与申请人作为受理凭证； 4.对申请人提交的申请资料不齐全或者不符合形式审查要求的，注明需要补正的内容，在5个工作日内出具申请资料补正通知书，告知申请人补正有关资料； 5.对申

15、请事项不属于本部门职权范围或该申请事项不需认证，不予接收，填写不予受理通知书。 二、审核 工作标准： 1审查申请书所填写项目应齐全； 2申请项目属于保健食品生产企业良好生产规范范围； 3所附申请资料齐全； 4. 申请资料及现场核查情况符合保健食品良好生产规范的要求。 岗位责任人：食品许可处审核人员 岗位职责及权限： 1.资料审查：食品许可处对企业提交的申请资料在15个工作日内组织审查，通过资料审查认为申请企业已经或基本达到GMP要求的，书面通知申请企业，安排进行现场审查；如果通过资料审查认为申请企业不符合现场审查条件的，也应书面通知申请企业，并说明理由； 2.现场审查：现场审查人员应为经过一定

16、GMP评价培训的食品药品监督人员。审查人员以“保健食品良好生产规范审查表”为基本依据，对被审查企业进行现场审查，对于现场审查中发现的事实和情况应该记录在案，并要求随从人员予以确认； 3.出具GMP审查结果报告：审查人员对现场审查的结果进行总结，在现场审查结束5个工作日内，根据“审查结果判定表”对被审查企业的GMP实施情况提出现场审核意见，上报市食品药品监督管理部门。 三、复核 工作标准： 1.程序应符合规定要求； 2.应在规定期限内完成； 3.对资料审核意见和现场核查结果进行确认。 岗位责任人：食品许可处处长 岗位职责及权限： 1.按复审标准对审核意见进行复核； 2.同意审核意见的，在审核文件

17、上填写复核意见，送审定人； 3.不同意审核意见的，应与审核人员沟通情况、交换意见后，提出复核意见和理由，填写在审核文件上，与申请资料一并转审定人员。 四、核定 工作标准： 1.程序应符合规定要求； 2.应在规定时限内完成； 3.对复核意见进行确认； 4.签发审定意见。 岗位责任人：分管局领导 岗位职责及权限： 1.按照审定标准进行核定； 2.同意复核意见的，签署核定意见，与申请材料一并转食品许可处审核人员； 3.不同意复核意见的，与复核人员交换意见后，提出核定意见及理由，与申请材料一并转食品许可处审核人员。 五.送达 工作标准： 1通知申请人携带企业介绍信、领取人身份证和受理通知书，领取保健食

18、品生产企业良好生产规范书面意见； 2及时通知申请人审查结果，在送达回执上签字。 岗位责任人：受理中心工作人员 岗位职责及权限： 1送达窗口人员负责通知申请人携带企业介绍信、领取人身份证和受理通知书，领取保健食品生产企业良好生产规范书面意见，在送达回执上签字，注明日期； 2装订成册，立卷归档。 受理地点： 重庆市食品药品监督管理局行政审批受理中心（电话：） 受理时间： 每周一至周五上午9：0011：30，下午14：0016：30（逢周五下午不对外受理） 咨询与投诉机构： 咨询：重庆市食品药品监督管理局食品许可处（电话：） 投诉：重庆市食品药品监督管理局监察室（电话：） 重庆市食品药品监督管理局政

19、策法规处（电话：）涉及重大决策事项、重要人事任免、重大项目安排和大额度资金使用等，具有决策、行政执法、行政许可、部门管理等决策、审批、自由裁量、事务管理决定权的领导岗位。To sum up, is divided into 9 main parts: 1. with regard to persisting and developing socialism with Chinese characteristics. 18 since the XIOn more than one occasion, General Secretary of the historical origin and d

20、evelopment process of socialism with Chinese characteristics, the road of socialism with Chinese characteristics, System Info, system, uphold and develop the understanding of socialism with Chinese characteristics is determined to have been profoundly expounded, further strengthened the party and th

21、e people adhere to and develop the confidence and determination of the socialism with Chinese characteristics. XI General Secretarys speech in this regard include the peoples yearning for a better life, that is our goal, closely focus on the development of socialism with Chinese characteristics stud

22、y and publicize the spirit of party 18, the unwaveringly adhere to the development of socialism with Chinese characteristics, the persistence and good use of Mao Ze-Dongs thought of soul. 2. with regard to the Chinese dream of realizing the great rejuvenation of the Chinese nation. 18 closing soon,

23、the new Central collective leadership when they visited the exhibition of the road to recovery, XI, General Secretary of the solemn declaration the great rejuvenation of the Chinese nation, the greatest dream of the Chinese nation in modern times. Zhihou, on more than one occasion, General Secretary

24、 expounded the scientific connotation of Chinese dream, realize the Chinese dream must take the road, carry forward the spirit and cohesion of Chinese forces, gradually formed the China dream, a strategic thought. And practice with the Chinese dream, reflects the history of the new session of the CP

25、C Central Committee, and conforms to the development trend and the people hope, embodies the greatest common divisor and the consensus of Chinese people at home and abroad, inspiring all peoples forging ahead in unity, the spirit of unswervingly follow the road of socialism with Chinese characterist

26、ics flags and high melody. This aspects XI General Secretary of speech main including achieved Chinese great revival is Chinese modern yilai most great of dream in 12th session national peoples Congress first times Conference Shang of speech work to dream into really in achieved China dream of vivid

27、 practice in the flying youth dream achieved China dream not only benefit people, and benefit world people innovation due its Shi, dream suitable have its potential achieved Chinese great revival is both at home and abroad Chinese children common of dream,. 3. on deepening reform. 18 since the XI Ge

28、neral Secretary for the first time to Study on the choice of the Guangdong, unequivocally express the unswervingly follow the road of reform and opening up power determination and courage. Partys 18 session adopted a decision to deepen reform, opened a new journey for deepening the reform in our country. Central has held 22 times full deepening reform led Group Conference, considered through more than 100 more items important reform programme, developed introduced more than 800 over