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

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 problems 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 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 partys policies, and so on. Bi Lifu Secretary pointed out that a quarter of the economic 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, 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 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 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 Carpenter 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 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 Interior 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 party 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(qǐng)須知項(xiàng)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(qǐng) 法定實(shí)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(cè)管理辦法（試行）（國(guó)家食品藥品監(jiān)督管理局令第19號(hào)）； 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(píng)價(jià)細(xì)則的通知（衛(wèi)法監(jiān)發(fā)200377號(hào)）。 收費(fèi)標(biāo)準(zhǔn)：不收費(fèi) 期限： 自受理之日起，15個(gè)工作日內(nèi)完成資料審查，10個(gè)工作日內(nèi)完成現(xiàn)場(chǎng)審查，5個(gè)工作日內(nèi)做出審查結(jié)論。申請(qǐng)人補(bǔ)正資料和整改所需時(shí)間不包括在內(nèi)。 程序 一、申請(qǐng)與接收： 申請(qǐng)人需提交以下資料： 1.保健食品GMP審查申請(qǐng)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(yíng)業(yè)執(zhí)照、保健食品批準(zhǔn)證書(shū)的復(fù)印件（新建廠無(wú)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(biāo)準(zhǔn)，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(chē)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.檢驗(yàn)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(bào)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(cè)報(bào)告（新開(kāi)辦的保健食品生產(chǎn)企業(yè)）； 13.國(guó)家食品藥品監(jiān)督管理局及市食品藥品監(jiān)督管理部門(mén)認(rèn)為有必要提供的其他資料。 申請(qǐng)資料要求： 1.紙質(zhì)申請(qǐng)書(shū)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(yè)加蓋公章或騎縫章，圖紙需標(biāo)明面積及尺寸； 3.申請(qǐng)書(shū)附電子文檔。 工作標(biāo)準(zhǔn)： 1.確定本次申請(qǐng)的項(xiàng)目是否屬于本部門(mén)職權(quán)范圍； 2.申請(qǐng)材料應(yīng)完整、清晰，要求簽字的須簽字，每份申請(qǐng)材料加蓋企業(yè)公章；使用A4紙打印或復(fù)印，裝訂成冊(cè)； 3.核對(duì)申請(qǐng)材料中同一項(xiàng)目的填寫(xiě)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(duì)申請(qǐng)資料與申請(qǐng)書(shū)上所選的附加資料目錄是否一致，核對(duì)申請(qǐng)書(shū)上自我申明欄是否簽字蓋章； 5.對(duì)申請(qǐng)材料進(jìn)行形式審查，保證申請(qǐng)材料的完整性.準(zhǔn)確性和一致性，對(duì)已接收的申請(qǐng)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(diǎn)申請(qǐng)資料，申請(qǐng)資料齊全的，發(fā)申請(qǐng)資料簽收單； 2.按照形式意見(jiàn)審查表查驗(yàn)申請(qǐng)材料； 3.對(duì)申請(qǐng)材料齊全、符合形式審查要求的，應(yīng)及時(shí)接收，填寫(xiě)受理通知書(shū)，受理中心將受理通知書(shū)交與申請(qǐng)人作為受理憑證； 4.對(duì)申請(qǐng)人提交的申請(qǐng)資料不齊全或者不符合形式審查要求的，注明需要補(bǔ)正的內(nèi)容，在5個(gè)工作日內(nèi)出具申請(qǐng)資料補(bǔ)正通知書(shū)，告知申請(qǐng)人補(bǔ)正有關(guān)資料； 5.對(duì)申請(qǐng)事項(xiàng)不屬于本部門(mén)職權(quán)范圍或該申請(qǐng)事項(xiàng)不需認(rèn)證，不予接收，填寫(xiě)不予受理通知書(shū)。 二、審核 工作標(biāo)準(zhǔn)： 1審查申請(qǐng)書(shū)所填寫(xiě)項(xiàng)目應(yīng)齊全； 2申請(qǐng)項(xiàng)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(qǐng)資料齊全； 4. 申請(qǐng)資料及現(xiàn)場(chǎng)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(duì)企業(yè)提交的申請(qǐng)資料在15個(gè)工作日內(nèi)組織審查，通過(guò)資料審查認(rèn)為申請(qǐng)企業(yè)已經(jīng)或基本達(dá)到GMP要求的，書(shū)面通知申請(qǐng)企業(yè)，安排進(jìn)行現(xiàn)場(chǎng)審查；如果通過(guò)資料審查認(rèn)為申請(qǐng)企業(yè)不符合現(xiàn)場(chǎng)審查條件的，也應(yīng)書(shū)面通知申請(qǐng)企業(yè)，并說(shuō)明理由； 2.現(xiàn)場(chǎng)審查：現(xiàn)場(chǎng)審查人員應(yīng)為經(jīng)過(guò)一定GMP評(píng)價(jià)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(duì)被審查企業(yè)進(jìn)行現(xiàn)場(chǎng)審查，對(duì)于現(xiàn)場(chǎng)審查中發(fā)現(xiàn)的事實(shí)和情況應(yīng)該記錄在案，并要求隨從人員予以確認(rèn)； 3.出具GMP審查結(jié)果報(bào)告：審查人員對(duì)現(xiàn)場(chǎng)審查的結(jié)果進(jìn)行總結(jié)，在現(xiàn)場(chǎng)審查結(jié)束5個(gè)工作日內(nèi)，根據(jù)“審查結(jié)果判定表”對(duì)被審查企業(yè)的GMP實(shí)施情況提出現(xiàn)場(chǎng)審核意見(jiàn)，上報(bào)市食品藥品監(jiān)督管理部門(mén)。 三、復(fù)核 工作標(biāo)準(zhǔn)： 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(duì)資料審核意見(jiàn)和現(xiàn)場(chǎng)核查結(jié)果進(jìn)行確認(rèn)。 崗位責(zé)任人：食品許可處處長(zhǎng) 崗位職責(zé)及權(quán)限： 1.按復(fù)審標(biāo)準(zhǔn)對(duì)審核意見(jiàn)進(jìn)行復(fù)核； 2.同意審核意見(jiàn)的，在審核文件上填寫(xiě)復(fù)核意見(jiàn)，送審定人； 3.不同意審核意見(jiàn)的，應(yīng)與審核人員溝通情況、交換意見(jiàn)后，提出復(fù)核意見(jiàn)和理由，填寫(xiě)在審核文件上，與申請(qǐng)資料一并轉(zhuǎn)審定人員。 四、核定 工作標(biāo)準(zhǔn)： 1.程序應(yīng)符合規(guī)定要求； 2.應(yīng)在規(guī)定時(shí)限內(nèi)完成； 3.對(duì)復(fù)核意見(jiàn)進(jìn)行確認(rèn)； 4.簽發(fā)審定意見(jiàn)。 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(biāo)準(zhǔn)進(jìn)行核定； 2.同意復(fù)核意見(jiàn)的，簽署核定意見(jiàn)，與申請(qǐng)材料一并轉(zhuǎn)食品許可處審核人員； 3.不同意復(fù)核意見(jiàn)的，與復(fù)核人員交換意見(jiàn)后，提出核定意見(jiàn)及理由，與申請(qǐng)材料一并轉(zhuǎn)食品許可處審核人員。 五.送達(dá) 工作標(biāo)準(zhǔn)： 1通知申請(qǐng)人攜帶企業(yè)介紹信、領(lǐng)取人身份證和受理通知書(shū)，領(lǐng)取保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范書(shū)面意見(jiàn)； 2及時(shí)通知申請(qǐng)人審查結(jié)果，在送達(dá)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(dá)窗口人員負(fù)責(zé)通知申請(qǐng)人攜帶企業(yè)介紹信、領(lǐng)取人身份證和受理通知書(shū)，領(lǐng)取保健食品生產(chǎn)企業(yè)良好生產(chǎn)規(guī)范書(shū)面意見(jiàn)，在送達(dá)回執(zhí)上簽字，注明日期； 2裝訂成冊(cè)，立卷歸檔。 受理地點(diǎn)： 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(shí)間： 每周一至周五上午9：0011：30，下午14：0016：30（逢周五下午不對(duì)外受理） 咨詢與投訴機(jī)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(xiàng)、重要人事任免、重大項(xiàng)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(mén)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 more 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 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 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 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-Dongs thought of soul. 2. with regard to the Chinese 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 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 strategic 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 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 peoples Congress first times Conference Sha