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目的:了解并掌握GMP对药厂的质量保证部门的职责要求。方法:GMP是药品安全生产的保证,是企业设立质量管理部门的准则,质量保证是质量管理体系的一部分,通过分析质量保证部门在GMP的要求下对药品的生产过程提供的保证要素,阐述QA的主要工作内容。结论:GMP是药品生产企业实现生产“符合性质量”产品的有效手段,QA只有严格执行GMP的要求,才能推动产品安全生产的不断提高。
Objectives: To understand and master GMP’s responsibility requirements for quality assurance departments of pharmaceutical companies. Methods: GMP is the guarantee of safe production of pharmaceuticals, the guideline for enterprises to set up quality control department, and quality assurance is a part of quality management system. By analyzing the guarantee elements provided by quality assurance department to the production process of pharmaceuticals under GMP requirements, QA The main content of the work. Conclusion: GMP is an effective means for drug manufacturers to produce “compliant quality” products. Only by strictly implementing GMP requirements can QA promote the continuous improvement of product safety.