保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范審查申請須知

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 solutio

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

3、wareness, lack of political responsibility 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 party's policies, and so on. Bi Lifu Secretary pointed out that a quarter of the e

4、conomic situation is very serious, 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,

5、 Hongshan district, economic prosperity, 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

6、of the party health, every organization is strong, 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&

7、quot; goal. Second, basic learning, focus on learning education 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 Carpen

8、ter NAO Carpenter, why do some carpenters made furniture to have everybody 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

9、primary school are learn had, first after six mark test practice conduct, 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 In

10、terior diplomatic defense, and rule party ruling army of important thought, 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 p

11、arty members and a deep understanding of a series of important speeches rich connotation and core ideas, which began so thoroughly Marxist positions保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范審查申請須知項目名稱：保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范審查申請 法定實施主體：重慶市食品藥品監(jiān)督管理局 依據(jù)： 1.保健食品注冊管理辦法（試行）（國家食品藥品監(jiān)督管理局令第19號）； 2.保健食品良好生產(chǎn)規(guī)范； 3.衛(wèi)生部關(guān)于印發(fā)保健食品良好生產(chǎn)規(guī)范審查方案與評價細則的通知（衛(wèi)法

12、監(jiān)發(fā)200377號）。 收費標準：不收費 期限： 自受理之日起，15個工作日內(nèi)完成資料審查，10個工作日內(nèi)完成現(xiàn)場審查，5個工作日內(nèi)做出審查結(jié)論。申請人補正資料和整改所需時間不包括在內(nèi)。 程序 一、申請與接收： 申請人需提交以下資料： 1.保健食品GMP審查申請表；2.保健食品生產(chǎn)管理和自查情況；3.企業(yè)的管理結(jié)構(gòu)圖；4.營業(yè)執(zhí)照、保健食品批準證書的復(fù)印件（新建廠無需提供）；5.各劑型主要產(chǎn)品的配方、生產(chǎn)工藝和質(zhì)量標準，工藝流程圖； 6.企業(yè)專職技術(shù)人員情況介紹；7.企業(yè)生產(chǎn)的產(chǎn)品及生產(chǎn)設(shè)備目錄；8.企業(yè)總平面圖及各生產(chǎn)車間布局平面圖（包括人流、物流圖，潔凈區(qū)域劃分圖，凈化空氣流程圖等）；9.

13、檢驗室人員、設(shè)施、設(shè)備情況介紹；10.質(zhì)量保證體系（包括企業(yè)生產(chǎn)管理、質(zhì)量管理文件目錄）；11.潔凈區(qū)域技術(shù)參數(shù)報告（潔凈度、壓差、溫濕度等）； 12.主要審查范圍所涉及品種的試生產(chǎn)產(chǎn)品的檢測報告（新開辦的保健食品生產(chǎn)企業(yè)）； 13.國家食品藥品監(jiān)督管理局及市食品藥品監(jiān)督管理部門認為有必要提供的其他資料。 申請資料要求： 1.紙質(zhì)申請書一式二份，其它資料一份； 2.所附的資料均須采用A4紙打印并逐頁加蓋公章或騎縫章，圖紙需標明面積及尺寸； 3.申請書附電子文檔。 工作標準： 1.確定本次申請的項目是否屬于本部門職權(quán)范圍； 2.申請材料應(yīng)完整、清晰，要求簽字的須簽字，每份申請材料加蓋企業(yè)公章；使

14、用A4紙打印或復(fù)印，裝訂成冊； 3.核對申請材料中同一項目的填寫是否一致，提供的復(fù)印件是否與原件一致、是否清晰； 4.核對申請資料與申請書上所選的附加資料目錄是否一致，核對申請書上自我申明欄是否簽字蓋章； 5.對申請材料進行形式審查，保證申請材料的完整性.準確性和一致性，對已接收的申請應(yīng)上網(wǎng)公告。 崗位責(zé)任人： 受理中心工作人員 崗位職責(zé)及權(quán)限： 1.受理中心接收資料人員按所需資料目錄清點申請資料，申請資料齊全的，發(fā)申請資料簽收單； 2.按照形式意見審查表查驗申請材料； 3.對申請材料齊全、符合形式審查要求的，應(yīng)及時接收，填寫受理通知書，受理中心將受理通知書交與申請人作為受理憑證； 4.對申請

15、人提交的申請資料不齊全或者不符合形式審查要求的，注明需要補正的內(nèi)容，在5個工作日內(nèi)出具申請資料補正通知書，告知申請人補正有關(guān)資料； 5.對申請事項不屬于本部門職權(quán)范圍或該申請事項不需認證，不予接收，填寫不予受理通知書。 二、審核 工作標準： 1審查申請書所填寫項目應(yīng)齊全； 2申請項目屬于保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范范圍； 3所附申請資料齊全； 4. 申請資料及現(xiàn)場核查情況符合保健食品良好生產(chǎn)規(guī)范的要求。 崗位責(zé)任人：食品許可處審核人員 崗位職責(zé)及權(quán)限： 1.資料審查：食品許可處對企業(yè)提交的申請資料在15個工作日內(nèi)組織審查，通過資料審查認為申請企業(yè)已經(jīng)或基本達到GMP要求的，書面通知申請企業(yè)，安

16、排進行現(xiàn)場審查；如果通過資料審查認為申請企業(yè)不符合現(xiàn)場審查條件的，也應(yīng)書面通知申請企業(yè)，并說明理由； 2.現(xiàn)場審查：現(xiàn)場審查人員應(yīng)為經(jīng)過一定GMP評價培訓(xùn)的食品藥品監(jiān)督人員。審查人員以“保健食品良好生產(chǎn)規(guī)范審查表”為基本依據(jù)，對被審查企業(yè)進行現(xiàn)場審查，對于現(xiàn)場審查中發(fā)現(xiàn)的事實和情況應(yīng)該記錄在案，并要求隨從人員予以確認； 3.出具GMP審查結(jié)果報告：審查人員對現(xiàn)場審查的結(jié)果進行總結(jié)，在現(xiàn)場審查結(jié)束5個工作日內(nèi)，根據(jù)“審查結(jié)果判定表”對被審查企業(yè)的GMP實施情況提出現(xiàn)場審核意見，上報市食品藥品監(jiān)督管理部門。 三、復(fù)核 工作標準： 1.程序應(yīng)符合規(guī)定要求； 2.應(yīng)在規(guī)定期限內(nèi)完成； 3.對資料審核意

17、見和現(xiàn)場核查結(jié)果進行確認。 崗位責(zé)任人：食品許可處處長 崗位職責(zé)及權(quán)限： 1.按復(fù)審標準對審核意見進行復(fù)核； 2.同意審核意見的，在審核文件上填寫復(fù)核意見，送審定人； 3.不同意審核意見的，應(yīng)與審核人員溝通情況、交換意見后，提出復(fù)核意見和理由，填寫在審核文件上，與申請資料一并轉(zhuǎn)審定人員。 四、核定 工作標準： 1.程序應(yīng)符合規(guī)定要求； 2.應(yīng)在規(guī)定時限內(nèi)完成； 3.對復(fù)核意見進行確認； 4.簽發(fā)審定意見。 崗位責(zé)任人：分管局領(lǐng)導(dǎo) 崗位職責(zé)及權(quán)限： 1.按照審定標準進行核定； 2.同意復(fù)核意見的，簽署核定意見，與申請材料一并轉(zhuǎn)食品許可處審核人員； 3.不同意復(fù)核意見的，與復(fù)核人員交換意見后，提出

18、核定意見及理由，與申請材料一并轉(zhuǎn)食品許可處審核人員。 五.送達 工作標準： 1通知申請人攜帶企業(yè)介紹信、領(lǐng)取人身份證和受理通知書，領(lǐng)取保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范書面意見； 2及時通知申請人審查結(jié)果，在送達回執(zhí)上簽字。 崗位責(zé)任人：受理中心工作人員 崗位職責(zé)及權(quán)限： 1送達窗口人員負責(zé)通知申請人攜帶企業(yè)介紹信、領(lǐng)取人身份證和受理通知書，領(lǐng)取保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范書面意見，在送達回執(zhí)上簽字，注明日期； 2裝訂成冊，立卷歸檔。 受理地點： 重慶市食品藥品監(jiān)督管理局行政審批受理中心（電話：） 受理時間： 每周一至周五上午9：0011：30，下午14：0016：30（逢周五下午不對外受理） 咨詢

19、與投訴機構(gòu)： 咨詢：重慶市食品藥品監(jiān)督管理局食品許可處（電話：） 投訴：重慶市食品藥品監(jiān)督管理局監(jiān)察室（電話：） 重慶市食品藥品監(jiān)督管理局政策法規(guī)處（電話：）涉及重大決策事項、重要人事任免、重大項目安排和大額度資金使用等，具有決策、行政執(zhí)法、行政許可、部門管理等決策、審批、自由裁量、事務(wù)管理決定權(quán)的領(lǐng)導(dǎo)崗位。To sum up, is divided into 9 main parts: 1. with regard to persisting and developing socialism with Chinese characteristics. 18 since the XIOn mo

20、re than one occasion, General Secretary of the historical origin and development 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

21、 have been profoundly expounded, further strengthened the party and the people adhere to and develop the confidence and determination of the socialism with Chinese characteristics. XI General Secretary's speech in this regard include the people's yearning for a better life, that is our goal,

22、 closely focus on the development of socialism with Chinese characteristics study 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-Dong's thought of soul. 2. with regard to the Chine

23、se dream of realizing the great rejuvenation of the Chinese nation. 18 closing soon, 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

24、of the Chinese nation in modern times." Zhihou, on more than one occasion, General Secretary 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 strategi

25、c thought. And practice with the Chinese dream, reflects the history of the new session of the CPC 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

26、ahead in unity, the spirit of unswervingly follow the road of socialism with Chinese characteristics 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 people's Congress first times Conferen