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药品GMP认证检查评定标准(中药制剂)

2022-12-19 来源：易榕旅网

一、药品GMP认证检查项目共259项，其中关键项目（条款号前加“*”）92项，一般项目167项。

二、药品GMP认证检查时，应根据申请认证的范围确定相应的检查项目,并进行全面检查和评定。

三、检查中发现不符合要求的项目统称为“缺陷项目”。其中，关键项目不符合要求者称为“严重缺陷”，一般项目不符合要求者称为“一般缺陷”。

四、缺陷项目如果在申请认证的各剂型或产品中均存在，应按剂型或产品分别计算。五、在检查过程中，企业隐瞒有关情况或提供虚假材料的，按严重缺陷处理。检查组应调查取证并详细记录。

六、结果评定

（一）未发现严重缺陷，且一般缺陷≤20%，能够立即改正的,企业必须立即改正；不能立即改正的,企业必须提供缺陷整改报告及整改计划，方可通过药品GMP认证。（二）严重缺陷或一般缺陷>20%的，不予通过药品GMP认证。

药品GMP认证检查项目序号条款检查内容机构与人员 1 2 3 *0301 0302 *0401 企业应建立药品生产和质量管理机构，明确各级机构和人员的职责。企业应配备一定数量的与药品生产相适应的具有相应的专业知识、生产经验及工作能力，应能正确履行其职责的管理人员和技术人员，主管生产和质量管理的企业负责人应具有医药或相关专业大专以上学历，并具有药品生产和质量管理经验，应对本规范的实施和产品质量负责。中药制剂生产企业主管药品生产和质量管理的负责人应具有中药专业知识。生产管理和质量管理的部门负责人应具有医药或相关专业大专以上学历，5 *0501 并具有药品生产和质量管理的实践经验，有能力对药品生产和质量管理中的实际问题做出正确的判断和处理。 6 7 8 9 10 *0502 0601 *0602 0603 0605 药品生产管理部门和质量管理部门负责人不得互相兼任。企业应建有对各级员工进行本规范和专业技术、岗位操作知识、安全知识等方面的培训制度、培训计划和培训档案。企业负责人和各级管理人员应定期接受药品管理法律法规培训。从事药品生产操作的人员应通过相应的专业技术培训后上岗，具有基础理论知识和实际操作技能。中药材、中药饮片验收人员应通过相关知识的培训后上岗，具有识别药材4 *0403 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard and the principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct \"Government credit + business credit\" credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create \"policy lowlands, Highlands, integrity of service land, development land\" as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the ...Since the educational practice of the mass line of the party, himself seriously in the education, practical control central \"eight rules\" and opposing \"the four winds\" and practicing \"three Suns\check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party's political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the party's political disciplines. Conscientiously abide by the party's political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party's political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further真伪、优劣的技能。 11 12 *0606 0607 从事药品质量检验的人员应通过相应专业技术培训后上岗，具有基础理论知识和实际操作技能。从事高生物活性、高毒性、强污染性、高致敏性及有特殊要求的药品生产操作和质量检验人员应通过专业的技术培训后上岗。从事生物制品制造的全体人员（包括清洁人员、维修人员）均应根据其生13 0608 产的制品和所从事的生产操作要求进行专业（卫生学、微生物学等）和安全防护培训。 14 15 0609 0701 进入洁净区的工作人员（包括维修、辅助人员）应定期进行卫生和微生物学基础知识、洁净作业等方面的培训及考核。应按本规范要求对各级员工进行定期培训和考核。厂房与设施 16 17 18 19 20 21 22 23 24 25 26 27 28 29

0801 0901 0902 1001 1101 1102 1103 1201 1202 1203 1204 1205 1207 1208 企业的生产环境应整洁；厂区地面、路面及运输等不应对药品生产造成污染；生产、行政、生活和辅助区总体布局应合理，不得互相妨碍。厂房应按生产工艺流程及所要求的空气洁净度级别进行合理布局。同一厂房内的生产操作和相邻厂房之间的生产操作不得相互妨碍。厂房应有防止昆虫和其它动物进入的有效设施。洁净室（区）的内表面应平整光滑、无裂缝、接口严密、无颗粒物脱落、耐受清洗和消毒。洁净室（区）的墙壁与地面的交界处应成弧形或采取其他措施，以减少灰尘积聚和便于清洁。中药生产的非洁净厂房地面、墙壁、天棚等内表面应平整，易于清洁，不易脱落，无霉迹。生产区应有与生产规模相适应的面积和空间用以安置设备、物料，便于生产操作，避免差错和交叉污染。中药材炮制中的蒸、炒、炙、煅等厂房应与其生产规模相适应，并有良好的通风、除尘、除烟、降温等设施。中药材、中药饮片的提取、浓缩等厂房应与其生产规模相适应，并有良好的排风和防止污染及交叉污染等设施。净选药材的厂房应设拣选工作台，工作台表面应平整、不易产生脱落物。净选药材的厂房应有必要的通风除尘设施。贮存区应有与生产规模相适应的面积和空间用于存放物料、中间产品、待验品和成品，避免差错和交叉污染。易燃、易爆、有毒、有害物质的生产和贮存的厂房设施应符合国家有关规2

treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard andthe principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct \"Government credit + business credit\" credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create \"policy lowlands, Highlands, integrity of service land, development land\" as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the ...Since the educational practice of the mass line of the party, himself seriously in the education, practical control central \"eight rules\" and opposing \"the four winds\" and practicing \"three Suns\check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party's political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the party's political disciplines. Conscientiously abide by the party's political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party's political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further定。 30 31 32 *1209 1301 1401 中药材的库房应分别设置原料库与净料库，毒性药材、贵细药材应分别设置专库或专柜。洁净室（区）内各种管道、灯具、风口以及其他公用设施应易于清洁。洁净室（区）应根据生产要求提供足够的照明。主要工作室的照度应达到300勒克斯；对照度有特殊要求的生产部位应设置局部照明。厂房应有应急照明设施。 33 *1501 进入洁净室（区）的空气必须净化，并根据生产工艺要求划分空气洁净度级别。洁净室（区）空气的微生物数和尘粒数应定期监测，监测结果应记录存档。34 1502 洁净室（区）在静态条件下检测的尘埃粒子数、浮游菌数或沉降菌数应符合规定。 35 36 37 38 1504 *1505 1506 *1601 洁净室（区）的净化空气如可循环使用，应采取有效措施避免污染和交叉污染。产尘量大的洁净室（区）经捕尘处理不能避免交叉污染时，其空气净化系统不得利用回风。空气净化系统应按规定清洁、维修、保养并作记录。洁净室（区）的窗户、天棚及进入室内的管道、风口、灯具与墙壁或天棚的连接部位应密封。空气洁净度等级不同的相邻房间（区域）之间或规定保持相对负压的相邻39 40 41 1602 1603 1604 房间（区域）之间的静压差应符合规定，应有指示压差的装置，并记录压差。空气洁净度等级相同的区域内，产尘量大的操作室应保持相对负压。非创伤面外用中药制剂及其它特殊的中药制剂生产厂房门窗应能密闭，必要时有良好的除湿、排风、除尘、降温等设施，人员、物料进出及生产操作应参照洁净室（区）管理。用于直接入药的净药材和干膏的配料、粉碎、混合、过筛等厂房门窗应能42 1605 密闭，有良好的通风、除尘等设施，人员、物料进出及生产操作应参照洁净室（区）管理。 43 44 45 1701 *1801 1901 洁净室（区）的温度和相对湿度应与药品生产工艺要求相适应。无特殊要求时，温度应控制在18－26℃，相对湿度应控制在45%－65%。洁净室（区）的水池、地漏不得对药品产生污染，100级洁净室（区）内不得设置地漏。不同空气洁净度级别的洁净室（区）之间的人员和物料出入，应有防止交叉污染的措施。 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is he objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard and

not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard and4

3101 设备的设计、选型、安装应符合生产要求，应易于清洗、消毒或灭菌，应便于生产操作和维修、保养，应能防止差错和减少污染。 5

103 *3402 104 105 106 107 108 109 110 111 112 *3403 3404 3501 3601 3602 3603 3604 *3605 3701 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard andthe principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct \"Government credit + business credit\" credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create \"policy lowlands, Highlands, integrity of service land, development land\" as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the ...Since the educational practice of the mass line of the party, himself seriously in the education, practical control central \"eight rules\" and opposing \"the four winds\" and practicing \"three Suns\check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party's political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the party's political disciplines. Conscientiously abide by the party's political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party's political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further113 3702 生产用模具的采购、验收、保管、维护、发放及报废应制定相应管理制度，应设专人专柜保管。物料 114 115 116 117 118 3801 3802 3803 3804 *3901 药品生产所用物料的购入、贮存、发放、使用等应制定管理制度。应有能准确反映物料数量变化及去向的相关记录。物料应按品种、规格、批号分别存放。原料药生产中难以精确按批号分开的大批量、大容量原料、溶媒等物料入库时应编号；其收、发、存、用应制定相应的管理制度。药品生产所用物料应符合药品标准、包装材料标准、生物制品规程或其它有关标准，不得对药品的质量产生不良影响。进口原料药、中药材、中药饮片应具有《进口药品注册证》（或《医药产品注册证》）或《进口药品批件》，应符合药品进口手续，应有口岸药品检验所的药品检验报告。非无菌药品上直接印字所用油墨应符合食用标准要求。直接接触药品的包装材料应经过批准。物料应按批取样检验。药品生产用中药材应按质量标准购入，产地应保持相对稳定。购入的中药材、中药饮片应有详细记录，每件包装上应附有明显标记，标明品名、规格、数量、产地、来源、采收（加工）日期。毒性药材、易燃易爆等药材外包装上应有明显的规定标志。鲜用中药材的购进、管理、使用应符合工艺要求。物料应从符合规定的供应商购进并相对固定，变更供应商需要申报的应按规定申报，供应商应经评估确定。对供应商评估情况、供应商资质证明文件、质量管理体系情况、购买合同等资料应齐全,并归档。购进的物料应严格执行验收、抽样检验等程序,并按规定入库。待验、合格、不合格物料应严格管理。不合格的物料应专区存放，应有易于识别的明显标志，并按有关规定及时处理。如采用计算机控制系统，应能确保对不合格物料及不合格产品不放行。对温度、湿度或其他条件有特殊要求的物料、中间产品和成品应按规定条件贮存。固体原料和液体原料应分开贮存；挥发性物料应避免污染其它物料；炮制、整理加工后的净药材应使用清洁容器或包装，应与未加工、炮制的药材严格分开。中药材、中药饮片的贮存、养护应按规程进行。 7

119 120 121 122 123 124 125 126 127 128 129 *3902 *3903 3904 *3905 4001 4002 4003 4004 4101 4102 *4201 130 4301 131 132

4302 4303 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is he objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard andthe principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct \"Government credit + business credit\" credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create \"policy lowlands, Highlands, integrity of service land, development land\" as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the ...Since the educational practice of the mass line of the party, himself seriously in the education, practical control central \"eight rules\" and opposing \"the four winds\" and practicing \"three Suns\check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party's political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the party's political disciplines. Conscientiously abide by the party's political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party's political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further133 134 135 136 137 *4401 *4402 4403 4404 *4405 麻醉药品、精神药品、毒性药品（包括药材）的验收、贮存、保管应严格执行国家有关规定。菌毒种的验收、贮存、保管、使用、销毁应执行国家有关医学微生物菌种保管的规定。生物制品用动物源性的原材料使用时应详细记录，内容至少包括动物来源、动物繁殖和饲养条件、动物的健康情况。用于疫苗生产的动物应是清洁级以上的动物。应建立生物制品生产用菌毒种的原始种子批、主代种子批和工作种子批系统。种子批系统应有菌毒种原始来源、菌毒种特征鉴定、传代谱系、菌毒种应为单一纯微生物、生产和培育特征、最适保存条件等完整资料。应建立生物制品生产用细胞的原始细胞库、主代细胞库和工作细胞库系统。138 139 140 141 142 143 144 145 *4406 4407 4501 *4601 4602 4603 4701 4702 细胞库系统应包括：细胞原始来源（核型分析、致瘤性）、群体倍增数、传代谱系、细胞应为单一纯化细胞系、制备方法、最适保存条件等。易燃、易爆和其它危险品的验收、贮存、保管应严格执行国家有关规定。物料应按规定的使用期限贮存，贮存期内如有特殊情况应及时复验。药品标签、说明书应与药品监督管理部门批准的内容、式样、文字相一致。标签、说明书应经企业质量管理部门校对无误后印制、发放、使用。印有与标签内容相同的药品包装物，应按标签管理。标签、说明书应由专人保管、领用。标签、说明书应按品种、规格专柜或专库存放，应凭批包装指令发放。标签应计数发放，由领用人核对、签名。标签使用数、残损数及剩余数之146 4703 和应与领用数相符。印有批号的残损标签或剩余标签应由专人负责计数销毁。 147 *4704 标签发放、使用、销毁应有记录。卫生 148 149 4801 4802 药品生产企业应有防止污染的卫生措施，应制定各项卫生管理制度，并由专人负责。洁净室（区）内应使用无脱落物、易清冼、易消毒的卫生工具，卫生工具应存放于对产品不造成污染的指定地点，并限定使用区域。药品生产车间、工序、岗位应按生产和空气洁净度等级的要求制定厂房清洁规程，内容应包括：清洁方法、程序、间隔时间，使用的清洁剂或消毒剂，清洁工具的清洁方法和存放地点。 150 4901 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is

the principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct \"Government credit + business credit\" credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create \"policy lowlands, Highlands, integrity of service land, development land\" as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the ...Since the educational practice of the mass line of the party, himself seriously in the education, practical control central \"eight rules\" and opposing \"the four winds\" and practicing \"three Suns\check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party's political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the party's political disciplines. Conscientiously abide by the party's political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party's political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further药品生产车间、工序、岗位应按生产和空气洁净度等级的要求制定设备清151 4902 洁规程，内容应包括：清洁方法、程序、间隔时间，使用的清洁剂或消毒剂，清洁工具的清洁方法和存放地点。药品生产车间、工序、岗位应按生产和空气洁净度等级的要求制定容器清152 4903 洁规程，内容应包括：清洁方法、程序、间隔时间，使用的清洁剂或消毒剂，清洁工具的清洁方法和存放地点。原料药生产更换品种时，应对设备进行彻底的清洁。在同一设备连续生产153 154 155 156 157 *4904 5001 *5002 5101 5201 同一品种，如有影响产品质量的残留物，更换批次时，也应对设备进行彻底的清洁。生产区不得存放非生产物品和个人杂物，生产中的废弃物应及时处理。在含有霍乱、鼠疫苗、免疫缺陷病毒（HIV）、乙肝病毒等高危病原体的生产操作结束后，对可疑的污染物品应在原位消毒，并单独灭菌后，方可移出工作区。更衣室、浴室及厕所的设置不应对洁净室（区）产生不良影响。工作服的选材、式样及穿戴方式应与生产操作和空气洁净度等级要求相一致，并不得混用。洁净工作服的质地应光滑、不产生静电、不脱落纤维和颗粒物。 158 159 160 161 162 5202 5203 5204 5301 5302 无菌工作服应能包盖全部头发、胡须及脚部，并能阻留人体脱落物。不同空气洁净度级别使用的工作服应分别清洗、整理，必要时消毒或灭菌，工作服洗涤、灭菌时不应带入附加的颗粒物质，应制定工作服清洗周期。 100,000级以上区域的洁净工作服应在洁净室（区）内洗涤、干燥、整理。洁净室（区）应限于该区域生产操作人员和经批准的人员进入，人员数量应严格控制，对进入洁净室（区）的临时外来人员应进行指导和监督。无菌操作区人员数量应与生产空间相适应，其确定依据应符合要求。在生物制品生产日内，没有经过明确规定的去污染处理，生产人员不得由163 164 165 *5304 5305 5401 操作活微生物或动物的区域到操作其他制品或微生物的操作区域。与生产过程无关的人员不得进入生产控制区，必须进入时，应穿着无菌防护服。从事生物制品生产操作的人员应与动物饲养人员分开。进入洁净室（区）的人员不得化妆和佩带饰物，不得裸手直接接触药品；100级洁净室（区）内操作人员不得裸手操作，当不可避免时手部应及时消毒。 166 167 5501 5502 洁净室（区）应定期消毒；使用的消毒剂不得对设备、物料和成品产生污染，消毒剂品种应定期更换，以防止产生耐药菌株。应制定消毒剂的配制规程并有配制记录。 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is he objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard and

6203 6204 审核日期、批准人及批准日期、颁发部门、生效日期、分发部门、标题及正文。批生产记录内容应包括：产品名称、规格、生产批号、生产日期、操作者、10

*6601 *6602 6701 6702 6801 6802 6803 *6804 *6901 7001 7002 *7003 *7004 药品应严格按照注册批准的工艺生产。生产工艺规程、岗位操作法或标准操作规程不得任意更改，如需更改时应按规定程序执行。每批产品应按产量和数量的物料平衡进行检查。如有显著差异，应查明原因，在得出合理解释、确认无潜在质量事故后，方可按正常产品处理。中药制剂生产中所需贵细、毒性药材或饮片应按规定监控投料，并有记录。批生产记录应及时填写、字迹清晰、内容真实、数据完整，并由操作人及复核人签名。批生产记录应保持整洁、不得撕毁和任意涂改；更改时，应在更改处签名，并使原数据仍可辨认。批生产记录应按批号归档，保存至药品有效期后一年。原料药应按注册批准的工艺生产。批生产记录应反映生产的全过程。连续生产的批生产记录，可为该批产品各工序生产操作和质量监控的记录。药品应按规定划分生产批次，并编制生产批号。生产前应确认无上次生产遗留物，并将相关记录纳入下一批生产记录中。生产中应有防止尘埃产生和扩散的措施。不同品种、规格的生产操作不得在同一操作间同时进行。有数条包装线同时进行包装时，应采取隔离或其他有效防止污染或混淆的11

*7005 7006 7007 7008 *7009 *7010 7011 *7012 7013 7014 *7015 7016 *7017 7018 7019 7020 7021 7022 7023 7024 *7101 7102 7201 无菌药品生产用直接接触药品的包装材料不得回收使用。生产过程中应防止物料及产品所产生的气体、蒸汽、喷雾物或生物体等引起的交叉污染。无菌药品生产中，应采取措施避免物料、容器和设备最终清洗后的二次污染。无菌药品生产用直接接触药品的包装材料、设备和其他物品的清洗、干燥、灭菌到使用时间间隔应有规定。无菌药品的药液从配制到灭菌或除菌过滤的时间间隔应有规定。无菌药品生产用物料、容器、设备或其他物品需进入无菌作业区时应经过消毒或灭菌处理。每一生产操作间或生产用设备、容器应有所生产的产品或物料名称、批号、数量等状态标志。非无菌药品液体制剂配制、过滤、灌封、灭菌等过程应在规定时间内完成。生产中的中间产品应规定贮存期和贮存条件。原料药生产使用敞口设备或打开设备操作时，应有避免污染措施。药品生产过程中，不合格的中间产品，应明确标示并不得流入下道工序；因特殊原因需处理使用时，应按规定的书面程序处理并有记录。药品生产过程中，物料、中间产品在厂房内或厂房间的流转应有避免混淆和污染的措施。应建立原料药生产发酵用菌种保管、使用、贮存、复壮、筛选等管理制度，并有记录。中药制剂生产过程中，中药材不应直接接触地面。含有毒性药材的药品生产操作，应有防止交叉污染的特殊措施。拣选后药材的洗涤应使用流动水，用过的水不应用于洗涤其他药材，不同药性的药材不应在一起洗涤。洗涤后的药材及切制和炮制品不应露天干燥。中药材、中间产品、成品的灭菌方法应以不改变药材的药效、质量为原则。直接入药的药材粉末，配料前应做微生物检查。中药材使用前应按规定进行拣选、整理、剪切、炮制、洗涤等加工，需要浸润的中药材应做到药透水尽。应根据产品工艺规程选用工艺用水，工艺用水应符合质量标准。工艺用水应根据验证结果，规定检验周期，定期检验，检验应有记录。产品应有批包装记录，批包装记录的内容应包括：待包装产品的名称、批12

treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard andthe principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct \"Government credit + business credit\" credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create \"policy lowlands, Highlands, integrity of service land, development land\" as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the ...Since the educational practice of the mass line of the party, himself seriously in the education, practical control central \"eight rules\" and opposing \"the four winds\" and practicing \"three Suns\check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party's political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the party's political disciplines. Conscientiously abide by the party's political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party's political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further号、规格；印有批号的标签和使用说明书以及产品合格证；待包装产品和包装材料的领取数量及发放人、领用人、核对人签名；已包装产品的数量；前次包装操作的清场记录（副本）及本次包装清场记录（正本）；本次包装操作完成后的检验核对结果、核对人签名；生产操作负责人签名。 229 230 7202 7203 药品零头包装应只限两个批号为一个合箱，包装箱外应标明合箱药品的批号，并建立合箱记录。原料药生产中，对可以重复使用的包装容器，应根据书面程序清洗干净，并去除原有的标签。每批药品的每一生产阶段完成后应由生产操作人员清场，填写清场记录。231 7301 清场记录内容应包括：工序、品名、生产批号、清场日期、检查项目及结果、清场负责人及复查人签名。清场记录应纳入批生产记录。质量管理 232 233 234 235 236 237 238 239 *7401 7402 7501 7502 7503 7504 *7505 *7506 药品生产企业的质量管理部门应负责药品生产全过程的质量管理和检验，应受企业负责人直接领导，并能独立履行其职责。质量管理部门应配备一定数量的质量管理和检验人员，应有与药品生产规模、品种、检验要求相适应的场所、仪器、设备。质量管理部门应制定和修订物料、中间产品和产品的内控标准和检验操作规程，应制定取样和留样制度。原料药留样包装应与产品包装相同或使用模拟包装，应保存在与产品标签说明相符的条件下，并按留样管理规定进行观察。质量管理部门应制定检验用设备、仪器、试剂、试液、标准品（或对照品）、滴定液、培养基、实验动物等管理办法。生物制品生产企业应使用由国家药品检验机构统一制备、标化和分发的国家标准品，应根据国家标准品制备其工作标准品。质量管理部门应有物料和中间产品使用、成品放行的决定权。生物制品生产用的主要原辅料（包括血液制品的原料血浆）应符合质量标准，并由质量管理部门检验合格签证发放。药品放行前应由质量管理部门对有关记录进行审核。审核内容应包括：配料、240 *7507 称重过程中的复核情况；各生产工序检查记录；清场记录；中间产品质量检验结果；偏差处理；成品检验结果等。符合要求并有审核人员签字后方可放行。 241 242 243 *7508 *7509 *7510 质量管理部门应审核不合格品处理程序。质量管理部门应对物料、中间产品和成品进行取样、检验、留样，并按试验原始数据如实出具检验报告。最终灭菌的无菌药品成品的无菌检查应按灭菌柜次取样检验。 treamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the \"four winds\" some outstanding issues 1, oppose formalism. One theory is that he didn't, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is he objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, innovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On hard and

c Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is he objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive leinnovation, lack of motivation. Emancipation did not end, innovation does not exist. In practical work, not your head, previous work experience, lack of innovation initiatives, study on the characteristics of propaganda and ideological work under the new situation through, grip on grassroots ideological trends and changes are not deep, to promote new initiatives and explore new methods of ideological and cultural work is not much, and some lack of relevance and timeliness. 4, discipline, lowering, and hard work are lacking. While working and enterprising spirit down. No real solution to treat yourself right, correctly treat past honors, their complacency, and work to see their scores more, less checking his own shortcomings, like to listen to the praise, satisfied face, online promotion, there are typical, and lack of high standards and strict requirements, the effect is real. Second hard drive less. On ning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is , rural culture team active, ... I'm not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible results. Third, 15

h; more passive learss. For examplehard and

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