委托加工管理规程

out city created, and care masses life, focus work, in-depth investigation, more out boutique masterpiece, makes we of research results more to into led of decision vision, more to in national some has effect of newspaper Shang published, for advance work, and publicity changde play due of role. Third, information submitted to be pragmatic. Quick and timely. The ancients said: for the time system; statement back for the time being, nothing. Therefore, the submission of information to do four, that is, find the problem faster, editorial writing, send and read faster approval and feedback to implement quickly. To be true and accurate. True mainly reflect the full picture of events, one is one, two, this is the life of the information. Accuracy is primarily qualitative and quantitative questions, quantitative objective of publicQualitative logic. To be reliable and useful. We submit information to have access to decision-making, to guide and promote the work and solve practical problems. Mixed cum. On the negative information and emergency information, rapid escalation in strict accordance with the procedures, firm, newspaper, newspapers, never late, fail to report, false claim and skimming. Investee 2. supervision and insist on, around and protecting their interests to touch the truth, seek practical results. Adhere to people-oriented, the most important thing is to realize, safeguard and develop the fundamental interests of the overwhelming majority of the people. We carry out inspection, so must go deep among the masses, go deep into the realities, always pay attention to the peoples livelihood, to grasp the public sentiment, and earnestly safeguard the benefit, addressing the masses are most concerned about and reflecting the strongest issues, efforts to solve the problem of decisions implemented and not implemented. One is to stick to principles. Right of inspection is one of the most important powers of the Office, should not only dare to use, but also with caution. So-called dared to use, is to hold a number of important issues, bold supervision over supervision, track inspection, problems are not solved do not pass, the blame does not hold did not miss, dissatisfaction of the masses did not miss, the real right of supervision authority, with the benefits. Call with caution, is supervising departments should strengthen the consciousness of authorized strictly according to procedure, preventing the supervision and excessive to prevent adding burden to grass-roots. To this end, the supervision Department of the Party Committee of supervision must be under city and County party Committee Secretary-General (Office). Second, we should focus on. Is the Governor, those related to the globalEvent, Governor the protracted difficult, strong Governor during emergency urgent. Not having special departments in charge of the General Governor, under the normal procedure can do good things not Governor, not authorized by County leaders, not the Governor. Third is to solve the problem. The purpose of supervision, to resolve the problem. To adhere to and further improve the文件名称采购技术管理规程文件编号：版号/改次：一、 目的：规范委托加工的生产管理,保证外出加工产品的质量。二、 适用范围：外出加工的品种三、 依据：药品生产质量管理规范及相关法规。四、 责任人：总经理、副总经理、生产负责人、质量负责人五、 内容：1进行委托加工前，应选择合适的厂家进行生产，应当符合下列条件：11持有与我公司委托加工药品的生产条件相适应的药品生产质量管理规范认证证书的药品生产企业，并且证书在有效期内；12交通便利；13价格合理；14能按要求及时加工并能保证产品的质量。2对加工企业进行简单的筛选后，由副总经理组织生产和质量相关人员组成的考查小组，对加工企业的生产规模和质量保证条件进行深入的考察，报总经理批准后最终确定加工厂家。3对于确定的加工厂家，我公司提供工艺规程、质量标准、检验方法等技术资料，并采购合格的原辅料，派出相关人员对生产全过程进行指导和监督，进行连继三批的试生产，检验后格后才能签订委托加工合同。4签订加工合同后，报相关资料到省药监局进行备案，获得批准并取得药品委托生产批件后，才可正式进行委托加工。5在生产加工过程中，我公司派出相关人员对生产全过程进行指导和监督，严格按GMP和公司的生产工艺进行生产，生产过程应有详细的记录，并且批生产记录应复印后随加工好的产品带回公司，复印的批生产记录存档备查。6药品委托生产批件有效期届满后应及时的提交有关材料，报省药监局办理延期手续。委托生产合同终止的，我公司应当及时办理药品委托生产批件的注销手续。附国家食品药品监督管理局令第14号药品生产监督管理办法于2004年5月28日经国家食品药品监督管理局局务会审议通过，现予公布，自公布之日起施行。二四年八月五日药品生产监督管理办法第四章药品委托生产的管理 第二十四条药品委托生产的委托方应当是取得该药品批准文号的药品生产企业。第二十五条药品委托生产的受托方应当是持有与生产该药品的生产条件相适应的药品生产质量管理规范认证证书的药品生产企业。第二十六条委托方负责委托生产药品的质量和销售。委托方应当对受托方的生产条件、生产技术水平和质量管理状况进行详细考查，应当向受托方提供委托生产药品的技术和质量文件，对生产全过程进行指导和监督。受托方应当按照药品生产质量管理规范进行生产，并按照规定保存所有受托生产文件和记录。第二十七条委托生产药品的双方应当签署合同，内容应当包括双方的权利与义务，并具体规定双方在药品委托生产技术、质量控制等方面的权利与义务，且应当符合国家有关药品管理的法律法规。第二十八条注射剂、生物制品（不含疫苗制品、血液制品）和跨省、自治区、直辖市的药品委托生产申请，由国家食品药品监督管理局负责受理和审批。疫苗制品、血液制品以及国家食品药品监督管理局规定的其他药品不得委托生产。麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品的委托生产按照有关法律法规规定办理。第二十九条本办法第二十八条规定之外的其他药品委托生产申请，由委托生产双方所在地省、自治区、直辖市（食品）药品监督管理部门负责受理和审批。第三十条药品委托生产的，由委托方向国家食品药品监督管理局或者省、自治区、直辖市（食品）药品监督管理部门提出申请，并提交本办法第三十四条规定的申请材料。（食品）药品监督管理部门参照本办法第七条的规定进行受理。第三十一条受理申请的（食品）药品监督管理部门应当自受理之日起20个工作日内，按照本章规定的条件对药品委托生产的申请进行审查，并作出决定；20个工作日内不能作出决定的，经本部门负责人批准，可以延长10个工作日，并应当将延长期限的理由告知委托方。经审查符合规定的，予以批准，并自书面批准决定作出之日起10个工作日内向委托方发放药品委托生产批件；不符合规定的，书面通知委托方并说明理由，同时告知其享有依法申请行政复议或者提起行政诉讼的权利。第三十二条药品委托生产批件有效期不得超过2年，且不得超过该药品批准证明文件规定的有效期限。第三十三条药品委托生产批件有效期届满需要继续委托生产的，委托方应当在有效期届满30日前，按照本办法第三十四条的规定提交有关材料，办理延期手续。委托生产合同终止的，委托方应当及时办理药品委托生产批件的注销手续。第三十四条药品委托生产申请材料项目：（一）委托方和受托方的药品生产许可证、营业执照复印件；（二）受托方药品生产质量管理规范认证证书复印件；（三）委托方对受托方生产和质量保证条件的考核情况；（四）委托方拟委托生产药品的批准证明文件复印件并附质量标准、生产工艺，包装、标签和使用说明书实样；（五）委托生产药品拟采用的包装、标签和使用说明书式样及色标；（六）委托生产合同；（七）受托方所在地省级药品检验所出具的连续三批产品检验报告书。委托生产生物制品的，其三批样品由受托方所在地省级药品检验所抽取、封存，由中国药品生物制品检定所负责检验并出具检验报告书；（八）受托方所在地省、自治区、直辖市（食品）药品监督管理部门组织对企业技术人员，厂房、设施、设备等生产条件和能力，以及质检机构、检测设备等质量保证体系考核的意见。药品委托生产延期申请所需要的申请材料项目：（一）委托方和受托方的药品生产许可证、营业执照复印件；（二）受托方药品生产质量管理规范认证证书复印件；（三）前次批准的药品委托生产批件复印件；（四）前次委托生产期间，生产、质量情况的总结；（五）与前次药品委托生产批件发生变化的证明文件。第三十五条委托生产药品的质量标准应当执行国家药品质量标准，其处方、生产工艺、包装规格、标签、使用说明书、批准文号等应当与原批准的内容相同。在委托生产的药品包装、标签和说明书上，应当标明委托方企业名称和注册地址、受托方企业名称和生产地址。第三十六条（食品）药品监督管理部门对药品委托生产申请进行审查时，应当参照执行本办法第二章第十条至第十二条的有关规定。第三十七条药品生产企业接受境外制药厂商的委托在中国境内加工药品的，应当在签署委托生产合同后30日内向所在地省、自治区、直辖市（食品）药品监督管理部门备案。所加工的药品不得以任何形式在中国境内销售、使用。第三十八条省、自治区、直辖市（食品）药品监督管理部门应当将药品委托生产的批准、备案情况报国家食品药品监督管理局。整个外脚手架工程涉及到搭设、维护及拆除三个阶段，根据各个阶段的不同工作内容，劳动力的需用情况不同。本工程主体施工进度要求较快，外脚手架工作量较大，需投入较多劳动力，外脚手架将根据现场分栋搭设。外脚手架维护阶段主要是配合外装单位进行施工，因此需用劳动力较少feelings survey, by looking up public sentiments to find problems. Problems will increase its special supervision, set up accounts, hold on to it. We should conscientiously implement the leading contracting matters, secured, had an answer to everything, then settles rate of 100%. Have an impact on some of the outstanding issues, supervision departments and information components together, play the supervisory role of the news media to promote problem solving. Investee 3. insist on a daily run, around the practice of truth catching efficiency, focus specification. To give full play to the party Office around connecting, coordinating internal and external features, contact, rally at all levels, to motivate every aspect, adhere to the truth, strengthening standardized management to achieve coherent, efficient and effective functioning of the daily work of the Party Committee. Is processing messages should strive to streamline, standardize and quality. Streamlining is to control the number of messages, compress messages, reducing procedures, improve message handling efficiency. Specifications, is to strictly enforce the ban issued by the Communist party authorities in document handling regulations and provincial and municipal regulations, conscientiously strengthen and improve communications management to ensure that party documents orderly. High quality, is to improve the quality of message processing, it is necessary to accurately implementing the intention of the Party Committee, clearance, good communications, policy program closed, ensuring that there is no error. Second meeting scheduled to ensure thorough, safe and efficient. Any arrangements for the meetings and events, carefully arranged, item-by-item interface implemented, sure. To vigorously streamline meetings, activities, number of pressure reduction, scale to ensure that leadership emerged from the General Conference and entertainment services, focus on big things, matters. Third, reception services should lay stress on humane, personal, cultural and human. Reception and work directly with people, reception services directly affecting the Office of party Committee The image of the region. At the same time strengthening th