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药品零售企业GSP认证现场检查项目及检查内容.doc

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1、the partys fine style, carry forward the traditional Chinese virtues, practicing the Socialist core values, vigorously carry forward the spirit of Jiao Yulu, Hongqi Canal spirit and spirit of persistence, honesty in politics, strict statesman, stick to the spiritual heights of the Communists. Four t

2、o devotion, as, do play a role in qualifying. Official Communist duty. To fulfill the partys purpose, maintain for the people themselves, and dedication, devotion, maintain pioneer, pioneering and enterprising spirit, active at the well-off extra practice, make contributions. The incentive function

3、of party organizations at all levels should give full play to advanced models, establish a representative, advanced and typical of the times, and guide the broad masses of party members to emulate. In honor of the 95 anniversary of founding as an opportunity to award in recognition of a number of ou

4、tstanding party members advanced grass-roots party organizations, outstanding party workers, and put the pioneer trees. Third, the “reform“ efforts for example, be sure to change into. Learning to teachEducation in order to solve the problem, if it does not solve the problem, it will form, goes thro

5、ugh the motions. To strengthen the consciousness of problems and insisted on problem-oriented, problem-solving learning education for traction, truly deep investigation into change, modification. A checked swing. Learning education programme for party-building in our city actually proposed to focus

6、on solution of fuzzy ideals and beliefs waver, consciousness, purpose of the party weak sense, honesty and self-discipline awareness is not strong, depressed, six issues of ethical misconduct study contents specific programmes for all party members and leading cadres above the county level shall foc

7、us on further refinement to the problems. Specific to every party member and every cadre, also requires a combination of actual and controlled, focused and really put yourself in, people see things, see, with their own specific problems to learn Constitution Party rules, series, address, so precisio

8、n to find the problem, laying a solid foundation for further corrective action. B to make change. For check put of problem, through established rectification Taiwan account, and take special supervision, and on account PIN, approach, insisted do side learn side modified, and that know that modified,

9、 while focused on put “two learn a do“ learning education rectification with grasp party of mass line education practice activities and “three strict three real“ topic education problem rectification combined up, consolidation expanded has made of rectification results, strongly corrected “for offic

10、er not for“, and Chi and endless corrected “four wind“, and regulation masses side of abuses, ensure work advance more powerful, and problem solution more completely. Third, we must consolidate our achievements. For more public, some party members who focus on the outstanding issues, combining conce

11、ntratedrectification and strengthening the management of daily education, the spirit of reform short of the complete system, pay close attention to system implementation, really make the party organization and party member education and strict management, solid. Finally, the “urge“ work on the lead,

12、 be sure to promote efficiency. “Two“ education, not on education educational, not working with the Centre two, must stick around the Center, serving the overall situation, coordinate, truly result-oriented and promote efficiency. Current and future a period, to tightly around coordination advance “

13、four a full“ strategy layout, winning full built society this a central and work overall, put carried out learning education as promoted work of important opportunities and powerful power, guide General members cadres insisted development first priority, active adapted economic development new norma

14、l, consciously practice line five big development concept, effective grasp supply side structural reform, to guarantees and improved livelihood, construction more high ecological vitality happiness of city. Last year, we carry out “three-three“ activities as a “three-three“ special education importa

15、nt, find education and effective platform to facilitate the combination of work. Reference this a good practices, provincial, and municipal decided in “two learn a do“ learning education in the carried out “five check five promoting“, the County District units to insisted put “two learn a do“ learni

16、ng education and “five check five promoting“ organic fusion, and common advance, do one plan layout, and one organization implementation, put carried out “two learn a do“ situation, and “five check five promoting“ situation as party work evaluation of importantContent, as an important aspect of mutu

17、al evaluation on party members, testing as an important basis for leading bodies and leading cadres performance and guide the broad masses of party members and cadres to study education opens up to the main economic and social development. At present, the overall smooth economic operation in our cit

18、y, but downward pressure is still high, faced a number of challenges and tests. Meanwhile, coincides with the city, County and township party committees this year general election year, how to really choose loyal, clean and serves as a good cadre, iron discipline of General Feng Qing Qi, Qi, Qi Shun

19、, swapped out Powerful good situation, is a real test for all of us. General work on “two“ to study the effect of education inspection, if the true series of party rules and Constitution speaks well and truly become a qualified party member, naturally we can deal with advance and retreat left turn t

20、reatment, proper organizational arrangements and selection, proper treatment of personal interests. To put carried out “two learn a do“ learning education with do reform development stable the work combined up, and seriously do Center work, and daily and job combined up, and guarantees improved live

21、lihood, and promote social harmony combined up, and completed the task combined药品零售企业 GSP 认证现场检查项目及检查内容 药品零售企业 GSP 认证检查项目共有 109 条,其中关键项目有 34 条,一般项目有 75 条。要一次性通过 GSP 认证检查,关键项目必须 100%符合规范要求,一般项目允许有 10%存在缺陷。现场检查时,应对所列项目及其涵盖内容进行全面检查,并逐项作出肯定与否定的评定。*5801、5802 一查 药品经营许可证的经营范围和经营方式二查药店现场经营的品种是否超越核定范围三查药品的购进

22、记录、零售卡是否有超核定范围的药品购销记录 四查经营方式是否超越核定范围 五查店堂是否悬挂合法的证照及证照内容是否相符六查店堂是否悬挂与执业人员要求(执业药师、从业药师或药师)相符的执业证明(驻店药师).注意执业药师的注册是否到该企业。检查连锁门店前是否有本零售连锁企业统一的商号和标志。连锁就是复印机,只有大小的区别。 5901(在所有检查完毕后才有结果) 一查是否有文件明确企业主要负责人二查企业负责人对药事法规的熟知程度三查在决策药品质量问题上,企业主要负责人是否有执行行为三查制度上是否有规定,制度和文件的签发上有体现6001、60026012 一查企业设置质量管理机构或专职质量管理人员的任

23、职证明文件二查质量管理机构或专职质量管理人员在文件中是否体现其负责企业质量管理工作,是否体现了以下 11 个方面的职能,是否在企业实际中体现6101*质量管理制度的结构一是制订制度的目的和原则二是制订制度的依据三是管理要求和职责权限the partys fine style, carry forward the traditional Chinese virtues, practicing the Socialist core values, vigorously carry forward the spirit of Jiao Yulu, Hongqi Canal spirit and sp

24、irit of persistence, honesty in politics, strict statesman, stick to the spiritual heights of the Communists. Four to devotion, as, do play a role in qualifying. Official Communist duty. To fulfill the partys purpose, maintain for the people themselves, and dedication, devotion, maintain pioneer, pi

25、oneering and enterprising spirit, active at the well-off extra practice, make contributions. The incentive function of party organizations at all levels should give full play to advanced models, establish a representative, advanced and typical of the times, and guide the broad masses of party member

26、s to emulate. In honor of the 95 anniversary of founding as an opportunity to award in recognition of a number of outstanding party members advanced grass-roots party organizations, outstanding party workers, and put the pioneer trees. Third, the “reform“ efforts for example, be sure to change into.

27、 Learning to teachEducation in order to solve the problem, if it does not solve the problem, it will form, goes through the motions. To strengthen the consciousness of problems and insisted on problem-oriented, problem-solving learning education for traction, truly deep investigation into change, mo

28、dification. A checked swing. Learning education programme for party-building in our city actually proposed to focus on solution of fuzzy ideals and beliefs waver, consciousness, purpose of the party weak sense, honesty and self-discipline awareness is not strong, depressed, six issues of ethical mis

29、conduct study contents specific programmes for all party members and leading cadres above the county level shall focus on further refinement to the problems. Specific to every party member and every cadre, also requires a combination of actual and controlled, focused and really put yourself in, peop

30、le see things, see, with their own specific problems to learn Constitution Party rules, series, address, so precision to find the problem, laying a solid foundation for further corrective action. B to make change. For check put of problem, through established rectification Taiwan account, and take s

31、pecial supervision, and on account PIN, approach, insisted do side learn side modified, and that know that modified, while focused on put “two learn a do“ learning education rectification with grasp party of mass line education practice activities and “three strict three real“ topic education proble

32、m rectification combined up, consolidation expanded has made of rectification results, strongly corrected “for officer not for“, and Chi and endless corrected “four wind“, and regulation masses side of abuses, ensure work advance more powerful, and problem solution more completely. Third, we must co

33、nsolidate our achievements. For more public, some party members who focus on the outstanding issues, combining concentratedrectification and strengthening the management of daily education, the spirit of reform short of the complete system, pay close attention to system implementation, really make t

34、he party organization and party member education and strict management, solid. Finally, the “urge“ work on the lead, be sure to promote efficiency. “Two“ education, not on education educational, not working with the Centre two, must stick around the Center, serving the overall situation, coordinate,

35、 truly result-oriented and promote efficiency. Current and future a period, to tightly around coordination advance “four a full“ strategy layout, winning full built society this a central and work overall, put carried out learning education as promoted work of important opportunities and powerful po

36、wer, guide General members cadres insisted development first priority, active adapted economic development new normal, consciously practice line five big development concept, effective grasp supply side structural reform, to guarantees and improved livelihood, construction more high ecological vital

37、ity happiness of city. Last year, we carry out “three-three“ activities as a “three-three“ special education important, find education and effective platform to facilitate the combination of work. Reference this a good practices, provincial, and municipal decided in “two learn a do“ learning educati

38、on in the carried out “five check five promoting“, the County District units to insisted put “two learn a do“ learning education and “five check five promoting“ organic fusion, and common advance, do one plan layout, and one organization implementation, put carried out “two learn a do“ situation, an

39、d “five check five promoting“ situation as party work evaluation of importantContent, as an important aspect of mutual evaluation on party members, testing as an important basis for leading bodies and leading cadres performance and guide the broad masses of party members and cadres to study educatio

40、n opens up to the main economic and social development. At present, the overall smooth economic operation in our city, but downward pressure is still high, faced a number of challenges and tests. Meanwhile, coincides with the city, County and township party committees this year general election year

41、, how to really choose loyal, clean and serves as a good cadre, iron discipline of General Feng Qing Qi, Qi, Qi Shun, swapped out Powerful good situation, is a real test for all of us. General work on “two“ to study the effect of education inspection, if the true series of party rules and Constituti

42、on speaks well and truly become a qualified party member, naturally we can deal with advance and retreat left turn treatment, proper organizational arrangements and selection, proper treatment of personal interests. To put carried out “two learn a do“ learning education with do reform development st

43、able the work combined up, and seriously do Center work, and daily and job combined up, and guarantees improved livelihood, and promote social harmony combined up, and completed the task combined四是与管理相关的记录表式五是必要的操作程序 检查制度的内容一是否符合现行的有关法律、法规、规章的要求二是否符合企业的实际情况,有无可操作性三是否内容完整四是否有具体考核项目(细则)和考核时间周期在检查制度的内容

44、时注意:一是制度的完整性;二是制度内容表述的准确性;三是制度与制度之间是否相互矛盾药品零售连锁门店的质量管理制度,除不包括购进、储存等方面的规定外,都与零售企业有关制度相同。*6102 制度的检查 一检查制度的相关工作人员对制度的了解情况,认识情况二检查企业对制度的执行情况是否制定了考核办法及是否与奖惩挂钩三查检查方式及检查结果是否有记录四查制度考核的结果*6201 一查岗位设置证明文件,是否有明确的质量管理工作的负责人员二查该人员的技术职称是否符合要求,看技术档案和技术职称证书三查该人员的实际管理能力*6301 一查岗位设置证明文件对照实际工作情况找出处方审核人员二查该人员的技术职称是否符合

45、要求,看技术档案和技术职称证书三查该人员是否在岗并履行处方审核工作四查该人员是否具备审核处方的能力*6401、6402 一要检查文件设置对照实际工作情况找出质量管理和验收工作岗位人员,检查质量管理和验收工作岗位人员的技术职称是否符合要求,看技术档案和技术职称证书二要从企业的名册中找出被检查门店的营业人员名单,再核查他们的学历是否达到要求,对于初中文化程度的营业员,须查企业人事档案,看从事药品经营工作的年限是否符合要求6501*6506 一要从企业的文件(或名册)中找出企业从事质量管理、验收及营业人员,查:是否经专业或岗位培训,是否经地市级(含) 以上药品监督管理部门考试合格,是否取得上岗证,文

46、件the partys fine style, carry forward the traditional Chinese virtues, practicing the Socialist core values, vigorously carry forward the spirit of Jiao Yulu, Hongqi Canal spirit and spirit of persistence, honesty in politics, strict statesman, stick to the spiritual heights of the Communists. Four

47、to devotion, as, do play a role in qualifying. Official Communist duty. To fulfill the partys purpose, maintain for the people themselves, and dedication, devotion, maintain pioneer, pioneering and enterprising spirit, active at the well-off extra practice, make contributions. The incentive function

48、 of party organizations at all levels should give full play to advanced models, establish a representative, advanced and typical of the times, and guide the broad masses of party members to emulate. In honor of the 95 anniversary of founding as an opportunity to award in recognition of a number of o

49、utstanding party members advanced grass-roots party organizations, outstanding party workers, and put the pioneer trees. Third, the “reform“ efforts for example, be sure to change into. Learning to teachEducation in order to solve the problem, if it does not solve the problem, it will form, goes through the motions. To strengthen the consciousness of problems and insisted on problem-oriented, problem-solving learning education for traction, truly deep investigation into change, modification. A checked swing. Learning education progra

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