金沙澳门官网糖果

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Quality Assurance

        公司的质量管理机构为质量部, 部长为蔡勋友,质量部下设质量保证和质量控制二个部门,负责药品生产全过程的质量管理和检验。

        公司质量管理执行质量受权人制度,质量受权人为张国全(省局已备案)。

        质量受权人的工作不受企业负责人和其他人员的干扰,独立行使过程监督权;成品放行权及质量否决权。

金沙澳门官网糖果        The company's quality management organization is the quality department, and the minister is Cai Xunyou. The quality department

consists  of  two departments: quality assurance(QA) and quality control(QC), which are responsible for the quality management and inspection

of the whole  process of drug production. 

金沙澳门官网糖果        The quality management of the company implements the quality authorized person system, and the quality authorized person is Zhang

Guoquan( He has been put on record by Hunan Food and Drug Administration). 

         The work of the quality authorized person shall not be interfered by the person in charge of the enterprise and other personnel, and shall independently exercise the power of supervision, the right of release of finished products and the right of quality veto.     

         

        生产过程严格按照GMP的要求进行生产管理;

金沙澳门官网糖果        每个原料均制定了生产工艺规程及关键生产工序的质量控制点,岗位SOP和岗位操作记录;

        生产操作前,严格按照要求对生产现场、工艺卫生、设备状况等进行检查,符合要求后才能进行生产;

金沙澳门官网糖果        Production procedure is strictly managed according to GMP requirements.

金沙澳门官网糖果        Each API has formulated production procedure regulations and key quality  control points ,SOP and operation records.

        Before production , inspect production field, sanitary condition, equipment condition, Only above that meeting the requirements can carry out production.

       

        生产的全过程严格执行工艺规程、岗位操作SOP;

        生产过程严格按照工艺、质量控制要点进行监控,对称量和投料实行复核制,及时预防、发现和消除事故差错;

金沙澳门官网糖果        严把中间产品质量,做到不合格中间体不得流入下道工序;

金沙澳门官网糖果        公司制订了返工、重新加工的管理制度;

        The whole procedure of production strictly carry out procedure regulations and operation SOP.

        The production procedure is strictly monitored according to the key points of procedure and quality control, and Checked the material of Weighing, Volume, Feeding ect. to avoid errors.

        The company has formulated the management system of Product rework  and remachine procedure.

       

金沙澳门官网糖果        公司制定了完善的物料验收、贮存、待验、取样、发放、退库管理制度。

        公司建立了不合格品管理制度,确保不合格的原辅料、包装材料不投入生产,不合格成品不出厂销售,不合格的中间产品不流入下道工序。

         建立有产品拼箱管理规程。

        The company has formulated a Perfect management system Include  material acceptance, storage, testing, sampling, granting, Return to Warehouse.

       The company has established a management system of unqualified  products to ensure that unqualified raw materials and packaging materials are  not put into production, unqualified end products are not sold out, anunqualified intermediate products do

not flow into the next production  procedure.

        Establishment of management rules for product assembly.

 

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