702澳门新葡萄娱乐场(澳门)股份有限公司-百度百科


质量

Quality


702澳门新葡萄娱乐场建立了“ 以科技为动力,以质量求生存,坚持质量技术领先;质量体系持续改进,打造精品质量,创702澳门新葡萄娱乐场品牌”的质量方针。为贯彻执行此质量方针,依据ICH指南和中国兽药GMP规范,欧盟GMP等要求实施贯穿于整个产品生命周期的质量管理体系。

Hanvet establishes the quality policy with the note taking science and technology as the driving force, striving for the survival by quality and pursuit of leadership in quality and technology, continuously improving quality management to produce competitive product with high quality and create Hanvet Brand. And to carry out the quality policy, the quality management system has been applied to drug substance and drug product throughout the whole lifecycle according to ICH guidelines, Chinese veterinary GMP and EU GMP etc.

研发阶段依据ICH Q8/ICH Q9/ICH Q10, 切实基于科学和风险的方法,运用设计空间和质量源于设计理念进行药品开研发、以及研发质量体系的架构。研发阶段建立了变更管理、知识管理、文档管理、数据管理、风险管理、CAPA管理和质量管理评审等程序流程以确保研发有序进展,相关研发活动符合药政法规要求,研发产品质量属性能精准设计和定义,工艺和产品的质量处于受控状态。

During the pharmaceutical development phase, the science and risk based approach, the concept of design space and quality by design are employed.  The corresponding quality management system including change control, knowledge management, document management, data governance, risk evaluation, CAPA and quality review management etc procedures ensures that development activities are conducted orderly and meet regulatory requirements. The critical quality attributes are correctly defined and process performance& product quality are maintained in a state of control. 

从技术转移、生产和产品生命中止阶段严格按严格按照中国兽药GMP规范、欧盟等法规指南要求建立了完善的质量体系,通过变更控制/自检/CAPA/过程控制/风险管理等不断完善优化质量体系, 确保产品质量工艺可控,以及药政法规的符合性。目前702澳门新葡萄娱乐场已通过APVMA GMP和中国农业部GMP认证,并正准备进行EU GMP认证。

During the phases of technology transfer, commercial production and product discontinuation, the quality management system is established and strictly follow Chinese veterinary GMP and Euro GMP etc requirement. The system is continually updated via change control management, self-inspection, process control, risk management,capa etc to ensure the quality product and process is in a good control status and comply with regulatory requirement. So far Hanvet has passed APVMA GMP and Chinese Agriculture GMP inspection.  

             

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