藥品生產(chǎn)管理課件：GDP(WHO)與GSP(SFDA)對(duì)比分析及新版GSP（征求意見(jiàn)稿）簡(jiǎn)介

1、GDP(WHO)與GSP(SFDA)對(duì)比分析及新版GSP（征求意見(jiàn)稿）簡(jiǎn)介發(fā)達(dá)國(guó)家監(jiān)管標(biāo)準(zhǔn)體系GMPGood Manufacturing PracticeGTPGood Trade PracticeGDPGood Distribution PracticeGBPGood Brokerage PracticeNational retail pharmacy licenseResource: Monika Dereque-Pois(GIRP Director General)23Resource: 梁毅，藥品經(jīng)營(yíng)質(zhì)量管理，中國(guó)醫(yī)藥科技出版社。一、GDP與GSP對(duì)比分析1、質(zhì)量責(zé)任Responsib

2、ility2、人員Personnel3、*采購(gòu)Procurement4、*運(yùn)輸Transportation 5、可追溯性Traceability 6、質(zhì)量體系Quality System7、假冒藥品Counterfeit Products8、投訴、召回、退貨Complaints/Recalls/Returns41.1質(zhì)量責(zé)任ResponsibilityGDP: All parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality o

3、f pharmaceutical products and the integrity of the distribution chain is maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or his or her agent. GSP: 規(guī)定藥品經(jīng)營(yíng)企業(yè)是藥品經(jīng)營(yíng)質(zhì)量的第一責(zé)任人，即把主要責(zé)任僅歸于供應(yīng)鏈中的經(jīng)營(yíng)企

4、業(yè)。應(yīng)強(qiáng)調(diào)責(zé)任的不可分割性：宏觀上強(qiáng)調(diào)整個(gè)醫(yī)藥供應(yīng)鏈的藥品質(zhì)量責(zé)任；微觀上強(qiáng)調(diào)藥品經(jīng)營(yíng)企業(yè)內(nèi)部人員的藥品質(zhì)量責(zé)任51.2人員PersonnelGDP: 7.PERSONNEL Training should be based on written standard operating procedures (SOPs) .GSP: 只是通過(guò)限定人員資質(zhì)的方式以確保其所負(fù)責(zé)的藥品質(zhì)量安全。6*1.3采購(gòu)ProcurementGDP: Authorized procurement and release procedures for all administrative and technical

5、 operations performed should be in place, to ensure that appropriate pharmaceutical products are sourced only from approved suppliers and distributed by approved entities. GSP:要求企業(yè)定期對(duì)供貨單位和采購(gòu)品種進(jìn)行質(zhì)量評(píng)價(jià)，對(duì)不符合要求的停止進(jìn)貨。7*1.4運(yùn)輸TransportationGDP:14. TRANSPORTATION AND PRODUCTS IN TRANSIT對(duì)藥品運(yùn)輸過(guò)程中涉及的運(yùn)輸工具和設(shè)備、發(fā)運(yùn)容

6、器等作了詳細(xì)的規(guī)定，要求有與保障運(yùn)輸中產(chǎn)品完整性相應(yīng)的管理措施，如加封，通過(guò)運(yùn)送和收獲時(shí)檢查封簽號(hào)的辦法保障運(yùn)輸中產(chǎn)品的完整性。GSP:需要補(bǔ)充運(yùn)送和收獲時(shí)檢查封簽號(hào)的辦法，以保障運(yùn)輸中產(chǎn)品的完整性，并增強(qiáng)防偽能力。81.5可追溯性Traceability GDP: 8.9-8.13 Traceability of pharmaceutical products There should be product traceability throughout the supply chain. This is a shared responsibility among the parties i

7、nvolved. There should be procedures in place to ensure and document traceability of products received and distributed to facilitate product recall. GSP: 要求建立計(jì)算機(jī)管理信息系統(tǒng)，以控制藥品購(gòu)進(jìn)、儲(chǔ)存、銷售等環(huán)節(jié)質(zhì)量管理的全過(guò)程。91.6質(zhì)量體系Quality SystemGDP: 8.QUALITY SYSTEM 8.8 Distributors should from time to time conduct risk assessmen

8、ts to assess potential risks to the quality and integrity of pharmaceutical products. GSP: 強(qiáng)調(diào)通過(guò)年度內(nèi)部評(píng)審不斷完善質(zhì)量管理體系，并且對(duì)內(nèi)部評(píng)審的組織、實(shí)施、程序、文件、報(bào)告等做出指導(dǎo)性規(guī)定。101.7假冒藥品Counterfeit ProductsGDP: 19. COUNTERFEIT PHARMACEUTICAL PRODUCTSGSP: 在質(zhì)量評(píng)價(jià)方面，要求“企業(yè)應(yīng)定期對(duì)供貨單位和采購(gòu)品種進(jìn)行質(zhì)量評(píng)價(jià)，對(duì)不符合要求的應(yīng)停止進(jìn)貨”。111.8投訴、召回、退貨Complaints/Recalls/

9、ReturnsGDP: 16. COMPLAINTS / 17. RECALLS / 18. RETURN PRODUCTS GSP: 只規(guī)定了職能和責(zé)任，并未對(duì)相應(yīng)系統(tǒng)的建立提出有詳細(xì)的規(guī)定，而且責(zé)任劃分太過(guò)寬泛。我也沒(méi)辦法，要不你接著吃，反正死不了！12ConclusionGDP: 充分運(yùn)用了供應(yīng)鏈的特性，從供應(yīng)鏈的各個(gè)環(huán)節(jié)入手加強(qiáng)責(zé)任監(jiān)管，措施更加嚴(yán)密。GSP？像我們的平時(shí)論文？13GSP的前世今生1959.7，衛(wèi)生部、商業(yè)部、化工部，關(guān)于保證與提高藥品質(zhì)量的指示；1979.7，衛(wèi)生部，關(guān)于貫徹執(zhí)行藥檢所工作條例的通知；1981.1，國(guó)家醫(yī)藥管理局，中國(guó)醫(yī)藥公司系統(tǒng)醫(yī)藥商品質(zhì)量管理辦法（

10、試行）；1984.6，中國(guó)醫(yī)藥公司，醫(yī)藥商品質(zhì)量管理規(guī)范；1984.9，全國(guó)人大，中華人民共和國(guó)藥品管理法；1986.6，國(guó)家醫(yī)藥管理局，醫(yī)藥行業(yè)質(zhì)量管理若干規(guī)定；1992.3，國(guó)家醫(yī)藥管理局，醫(yī)藥商品質(zhì)量管理規(guī)范；1993.6，中國(guó)醫(yī)藥商業(yè)協(xié)會(huì)，醫(yī)藥商品質(zhì)量管理規(guī)范實(shí)施指南；2000.7，國(guó)家藥監(jiān)局，藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范；2011.8，國(guó)家藥監(jiān)局，藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范（征求意見(jiàn)稿）；14新版GSP（征求意見(jiàn)稿）簡(jiǎn)介 舊版GSP第一章總則第二章質(zhì)量管理原則機(jī)構(gòu)與職責(zé)質(zhì)量改進(jìn)和風(fēng)險(xiǎn)管理第三章人員與培訓(xùn)原則 批發(fā)企業(yè)質(zhì)量關(guān)鍵人員 零售質(zhì)量關(guān)鍵人員健康檢查及人員衛(wèi)生第四章設(shè)施、設(shè)備及驗(yàn)證原則庫(kù)房及設(shè)備零售營(yíng)業(yè)場(chǎng)所及設(shè)備計(jì)算機(jī)系統(tǒng)校準(zhǔn)與驗(yàn)證第五章文件與記錄原則批發(fā)企業(yè)管理文件藥品零售管理文件記錄及憑證第六章藥品采購(gòu)原則購(gòu)進(jìn)審核購(gòu)進(jìn)記錄及票據(jù)第七章藥品儲(chǔ)存管理原則藥品驗(yàn)收入庫(kù)藥品儲(chǔ)存與養(yǎng)護(hù)藥品出庫(kù)復(fù)核第八章藥品銷售管理原則批發(fā)銷售藥品零售陳列與檢查藥品零售銷售第九章運(yùn)輸與配送原則運(yùn)輸措施運(yùn)輸管理第十章售后投訴藥品追溯和召回藥品退回藥品不良反應(yīng)