药品退货与召回管理规程

药品退货与召回管理规程内容摘要：

年 月 日 完成情况 : 召回 情况 评审 质管部： 年 月 日 管理性文件 药品退货与召回管理规程 — SMP 文本编号 SMPFY003ZL03 版本号 03 生效日期 20200901 第 18 页 共 65 页 附件 5：《召回总结报告》 附件 6：《 安全隐患调查评估报告 》 安全隐患调查评估报告 产品名称 批 号 数量 销售数量 流通区域 范围 隐患发现 用户投诉□ 药监等部门检查□ 自检发现□ 发现时间 年 月 日 不良事件种类 范 围 不良事件原因 产品与法定标准一致性 是□ 否□ 使用情况与说明书等一致性 是□ 否□ 生产工艺与批准一致性 是□ 否□ 是否按 GMP等标准生产 是□ 否□ 产品储运与规定的一致性 是□ 否□ 使用人群构成比例 成人儿童老年 危害发生情况 可能发生□ 已发生□ 未发生□ 对主要人群的影响 特殊危害 老年□ 儿童□ 孕妇□ 肝肾功能不全者□ 外科病人□ 其他□ 危害的严重程度 轻微□ 一般□ 严重□ 危害的紧急程度 紧急□ 一般□无关紧 要□ 危害后果 召回分级 一级□ 二级□ 三级□ 召回时限 日内 管理性文件 药品退货与召回管理规程 — SMP 文本编号 SMPFY003ZL03 版本号 03 生效日期 20200901 第 19 页 共 65 页 （英文版 ） Two regulations promulgated for implementation is in the party in power for a long time and the rule of law conditions, the implementation of prehensive strictly strategic plan, implementation in accordance with the rules and discipline to manage the party, strengthen innerparty supervision of major initiatives. The two regulations supporting each other, the code adhere to a positive advocate, focusing on morality is of Party members and Party leading cadres can see, enough to get a high standard。 rule around the party discipline, disciplinary ruler requirements, listed as negative list, focusing on vertical gauge, draw the party anizations and Party members do not touch the bottom line . Here, the main from four square face two party rules of interpretation: the first part introduces two party Revised regulations the necessity and the revision process。 the second part is the interpretation of the two fundamental principles of the revision of laws and regulations in the party。 the third part introduces two party regulations modified the main changes and needs to grasp several key problems。 the fourth part on how to grasp the implementation of the two regulations of the party. 管理性文件 药品退货与召回管理规程 — SMP 文本编号 SMPFY003ZL03 版本号 03 生效日期 20200901 第 20 页 共 65 页 code and Regulations revised the necessity and revised history of the CPC Central Committee the amendment to the Chinese Communist Party members and leading cadres honest politics several guidelines and Chinese Communist Party discipline and Punishment Regulations column 1 by 2020 to strengthen party laws and regulations focus. Two party regulations revision work lasted a Years, pooling the wisdom of the whole party, ideological consensus, draw historical experience, respect for the wisdom of our predecessors, which reflects the unity of inheritance and innovation。 follow the correct direction, grasp the limited goals, adhere to the party39。 s leadership, to solve the masses of the people reflect a focus on the problem. The new revision of the code and rule , reflects the party39。 s 18 and the eighth session of the third, the spirit of the fourth plenary session, reflecting the experience of studying and implementing the General Secretary Xi Jinping series of important speech, reflects the party39。 s eighteen years prehensive strictly practice. (a) revised two regulations of the party need of the ICAC guidelines in in 1997 Leaders as members of the Communist Party of China clean politics certain criteria (Trial) based on revised, the 管理性文件 药品退货与召回管理规程 — SMP 文本编号 SMPFY003ZL03 版本号 03 生效日期 20200901 第 21 页 共 65 页 promulgation and implementation of January 2020, to strengthen the construction of the contingent of leading cadres play an important role. But with the party to manage the party strictly administering the deepening, has not been able to fully meet the actual needs. Content is too plicated, eight prohibition, 52 are not allowed to hard to remember, and also difficult to put into practice。 the second is concisely positive advocated by the lack of prohibited provisions excessive, no autonomy requirements。 the third is banned terms and discipline law, both with the party discipline, disciplinary regulations repeat and Criminal law and other laws and regulations repeat。 the fourth is to clean the theme is not prominent, not for the existing problems, and is narrow, only needle of countylevel leading cadres above. rule is in 1997 Chinese Communist Party disciplinary cases (Trial) based on revision, in December 2020 the promulgation and implementation, to strengthen the construction of the party play very important role. Along with the development of the situation, which many provisions have been unable to fully meet the prehensive strictly administering the practice needs. One is Ji law, more than half of the provisions and criminal 管理性文件 药品退货与召回管理规程 — SMP 文本编号 SMPFY003ZL03 版本号 03 生效日期 20200901 第 22 页 共 65 页 law and other countries laws and regulations Repetition。 two is the political discipline regulations is not prominent, not specific, for violation of the party constitution, damage the authority of Party Constitution of misconduct lack necessary and serious responsibility to pursue。 third is the main discipline for the leading cadres, does not cover all Party members. Based on the above situation, need to the criterion of a clean and honest administration and rule the two is likely to be more relevant regulations first amendment. By revising, really put the authority of Party discipline, the seriousness in the party tree and call up the majority of Party members and cadres of the party constitution of party passes party consciousness. (II) two party regulations revision process the Central Committee of the Communist Party of China attaches great importance to。