Study on the construction and optimization of pharmaceutical engineering quality management system
制药工程质量管理体系的构建与优化研究

摘要

在全球医药产业蓬勃发展的大背景下，制药工程的质量把控成为核心要点。药品关乎民众生命健康，其质量的稳定性与可靠性至关重要。本研究深度聚焦制药工程质量管理体系，全面审视当前体系架构。进而针对性地从多维度探索切实可行的优化策略，涵盖强化人员培训与考核、精细化设备维护规划、严格物料采购筛选流程以及标准化工艺管控手段等。旨在全方位提升药品质量，为公众用药安全筑牢根基，助力制药产业朝着高质量、可持续方向大步迈进。

Abstract

In the context of the thriving global pharmaceutical industry, quality control in pharmaceutical engineering has become a core focus. Medicines are vital to public health, and their stability and reliability are paramount. This study delves into the quality management system of pharmaceutical engineering, thoroughly examining the current framework. It then explores practical optimization strategies from multiple dimensions, including enhancing personnel training and evaluation, refining equipment maintenance planning, strictly controlling material procurement processes, and standardizing process control methods. The aim is to comprehensively improve drug quality, solidify the foundation for public medication safety, and propel the pharmaceutical industry toward high-quality, sustainable development.