中药饮片安全生产持续质量管理应用效果研究

Study on application effect of continuous quality management in safety production of Chinese herbal pieces

目的:探讨中药饮片安全生产持续质量管理应用效果。方法:将2019年某中药类企业生产的500份中药饮片纳入对照组,并实施常规质量管理,另外将2020年某中药类企业生产的500份中药饮片纳入观察组,生产过程中对其实施PDCA持续质量管理,对比两组不通过率、收回GMP证书率、产品召回率及两组不合格率。结果:观察组中药饮片不通过率、收回GMP证书率及产品召回率均低于对照组(P<0.05);观察组中药饮片不合格率4.20%,显著低于对照组的17.00% (P<0.05)。结论:中药饮片生产过程中,实施PDCA持续质量管理可提高中药饮片通过率、减少收回GMP证书率、产品召回率,提高中药饮片合格率,使得中药材的生产更加标准化及规模化,以保证中药饮片生产质量。

Objective:To explore the effect of continuous quality management in the safety production of Chinese herbal pieces.Method:500 pieces of Chinese medicine produced by a Chinese medicine enterprise in 2019 were included in the control group and routine quality management was implemented.In addition,500 pieces of Chinese medicine produced by a Chinese medicine enterprise in 2020 were included in the observation group.PDCA continuous quality management was applied in the production process,and the failure rate,GMP certificate recovery rate,product recall rate and unqualified rate of the two groups were compared.Result:The rate of failure,GMP certificate recovery and product recall rate of the observation group were lower than that of the control group(P <0.05),and the unqualified rate of the observation group was 4.20% which was significantly lower than that of the control group(P <0.05).Conclusion:PDCA can improve the pass rate,reduce the recovery of GMP certificate and product recall rate,improve the qualified rate of Chinese herbal pieces,make the production of Chinese herbal medicine more standardized and large-scale,so as to ensure the quality of production of Chinese herbal pieces.