摘要
医药市场规模持续扩大,原料药质量备受重视且法规监管趋于完善,我国原料药产业虽有所发展,但部分企业质量管理存在不足。G制药厂在原料药制造领域有一定优势,却也面临生产质量管理挑战。文章通过问卷分析G制药厂当前生产质量管理现状,主要问题为人员存在人为错误或操作不规范、设备存在老化或故障。引入PDCA循环法,从人员和设备两方面制定改进措施,涵盖计划、执行、核查、处理阶段,旨在提升G制药厂原料药生产质量管理水平,增强企业市场竞争力,为原料药生产质量管理提供实践参考。
Pharmaceutical market scale continues to expand,the quality of APIs is highly valued and regulations tend to improve,China’s API industry has developed,but some enterprises have quality management deficiencies.G pharmaceuticals has certain advantages in the field of API manufacturing,but also faces challenges in production quality management.This paper analyzes the current production quality management status of G pharmaceutical factory through questionnaires,and the main problems are human error or irregular operation of personnel,aging or failure of equipment.The PDCA cycle method was introduced to formulate improvement measures in terms of human and equipment,covering the stages of planning,implementation,verification and treatment,aiming to improve the level of quality management of API production in G pharmaceutical factory,enhance the competitiveness of the enterprise in the market,and provide practical references for the quality management of API production.
作者
赵昌
ZHAO Chang(College of Economics and Management,North China University of Science and Technology,Tangshan 063210,China)
出处
《化工管理》
2025年第34期9-12,共4页
Chemical Management
关键词
PDCA循环法
质量管理改进
制药厂
PDCA cycle method
quality management improvement
pharmaceutical factory
