藥品生產(chǎn)管理課件：GDP(WHO)與GSP(SFDA)對比分析及新版GSP（征求意見稿）簡介

1、GDP(WHO)與GSP(SFDA)對比分析及新版GSP（征求意見稿）簡介發(fā)達(dá)國家監(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)營質(zhì)量管理，中國醫(yī)藥科技出版社。一、GDP與GSP對比分析1、質(zhì)量責(zé)任Responsib

2、ility2、人員Personnel3、*采購Procurement4、*運輸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)營企業(yè)是藥品經(jīng)營質(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)營企

4、業(yè)。應(yīng)強調(diào)責(zé)任的不可分割性：宏觀上強調(diào)整個醫(yī)藥供應(yīng)鏈的藥品質(zhì)量責(zé)任；微觀上強調(diào)藥品經(jīng)營企業(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)定期對供貨單位和采購品種進行質(zhì)量評價，對不符合要求的停止進貨。7*1.4運輸TransportationGDP:14. TRANSPORTATION AND PRODUCTS IN TRANSIT對藥品運輸過程中涉及的運輸工具和設(shè)備、發(fā)運容

6、器等作了詳細(xì)的規(guī)定，要求有與保障運輸中產(chǎn)品完整性相應(yīng)的管理措施，如加封，通過運送和收獲時檢查封簽號的辦法保障運輸中產(chǎn)品的完整性。GSP:需要補充運送和收獲時檢查封簽號的辦法，以保障運輸中產(chǎn)品的完整性，并增強防偽能力。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: 要求建立計算機管理信息系統(tǒng)，以控制藥品購進、儲存、銷售等環(huán)節(jié)質(zhì)量管理的全過程。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: 強調(diào)通過年度內(nèi)部評審不斷完善質(zhì)量管理體系，并且對內(nèi)部評審的組織、實施、程序、文件、報告等做出指導(dǎo)性規(guī)定。101.7假冒藥品Counterfeit ProductsGDP: 19. COUNTERFEIT PHARMACEUTICAL PRODUCTSGSP: 在質(zhì)量評價方面，要求“企業(yè)應(yīng)定期對供貨單位和采購品種進行質(zhì)量評價，對不符合要求的應(yīng)停止進貨”。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)任劃分太過寬泛。我也沒辦法，要不你接著吃，反正死不了！12ConclusionGDP: 充分運用了供應(yīng)鏈的特性，從供應(yīng)鏈的各個環(huán)節(jié)入手加強責(zé)任監(jiān)管，措施更加嚴(yán)密。GSP？像我們的平時論文？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，國家醫(yī)藥管理局，中國醫(yī)藥公司系統(tǒng)醫(yī)藥商品質(zhì)量管理辦法（

10、試行）；1984.6，中國醫(yī)藥公司，醫(yī)藥商品質(zhì)量管理規(guī)范；1984.9，全國人大，中華人民共和國藥品管理法；1986.6，國家醫(yī)藥管理局，醫(yī)藥行業(yè)質(zhì)量管理若干規(guī)定；1992.3，國家醫(yī)藥管理局，醫(yī)藥商品質(zhì)量管理規(guī)范；1993.6，中國醫(yī)藥商業(yè)協(xié)會，醫(yī)藥商品質(zhì)量管理規(guī)范實施指南；2000.7，國家藥監(jiān)局，藥品經(jīng)營質(zhì)量管理規(guī)范；2011.8，國家藥監(jiān)局，藥品經(jīng)營質(zhì)量管理規(guī)范（征求意見稿）；14新版GSP（征求意見稿）簡介 舊版GSP第一章總則第二章質(zhì)量管理原則機構(gòu)與職責(zé)質(zhì)量改進和風(fēng)險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)備及驗證原則庫房及設(shè)備零售營業(yè)場所及設(shè)備計算機系統(tǒng)校準(zhǔn)與驗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原則購進審核購進記錄及票據(jù)第七章藥品儲存管理原則藥品驗收入庫藥品儲存與養(yǎng)護藥品出庫復(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輸與配送原則運輸措施運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)