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      按照cGMP管理理念,从原辅包物料的动态审计着手,严格控制生产物料的质量。
严格按照注册申报的生产工艺、关键控制参数以及质量标准进行生产和检验放行,确保每批产品质量符?#29616;?#37327;标准的要求。
      加强生产人员和质量检验人员的培训,建立严格的操作流程和各个岗位SOP。
加强生产监督和管理,对于生产过程中的任何偏差,均按照GMP的要求,进行风险评估和纠偏分析,保证每批产品的批间质量均一。
      提高生产管理效率,在生产管理中明确目标和责任人。从一线生产员工至车间主任再到生产总监和总经理,责任明细,分工到岗。坚决杜绝任何违法违规的生产行为。
      ?#20013;?#19981;断的GMP管理理念的学习和更新,重点关注国家局的技术要求,并及时强化技术要求的执行。
      卓越有效的生产成?#31350;?#21046;管理,在确保产品质量的前提下,在生产过程中优化生产和工序。
      在产品全生命周期?#20013;?#19981;断的完善产品质量,严格按照ICH以及国家局的技术要求,不断追求高品质的产品。

 

According to cGMP management concept, the quality of production materials are strictly controlled via the dynamic audit of raw and auxiliary materials.

Strictly following the registered production process, key control parameters and quality standards, production and inspection shall be carried out to ensure that the quality can meet the requirements of quality standards among batches of products

Strengthen the training of production personnel and quality inspection personnel, establishing strict operation process and post SOP.

Strengthen production supervision and management, for any deviation in the production process, in accordance with the requirements of GMP, risk assessment and correction analysis are used to ensure uniform quality among batches of products .

Improve the efficiency of production management, clarify objectives and responsible persons in production management. From front-line production staff to workshop director to production director and general manager, make division of labor for them. Resolutely put an end to any illegal production behavior.
Learn and update GMP management concept continuously, focuse on the technical requirements of the National Bureau, and timely strengthen the implementation of technical requirements.
Excellent and effective production cost control management, on the premise of ensuring product quality, optimize production and procedures in the production process.
In the whole product life cycle continuously improve the product quality, in accordance with the technical requirements of the ICH and the National Bureau strictly , constantly pursue high-quality products.

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