通过对质量定义的阐述,明确QA人员的工作范围,并且通过注射剂冻干粉针品种的实际制剂车间的工作要点,阐述QA人员在制剂企业中的关键作用,最后阐述了QA工作中面临的问题及呼吁各生产企业应该注重QA人员,公司效益的产生不仅取决于生产更取决于对产品质量的保证。 Through the definition of quality, the scope of work of QA personnel is clarified, and the key points of QA personnel’s role in formulation enterprises are elaborated through the work points of the actual preparation workshops for injection of powder freeze-dried powder varieties. Finally, the problems faced by QA work are described And calls on all manufacturing enterprises should focus on QA personnel, the company benefits not only depends on the production depends on the product quality assurance.