摘要
制药用水系统作为药品生产过程中的关键环节，其设计与验证直接影响药品的质量和安全性。本研究基于现行GMP法规要求，结合实际生产需求，旨在构建一套科学、高效的制药用水系统设计方案，并通过系统化的验证流程确保其稳定性和可靠性。研究采用风险评估方法对系统设计进行全面分析，优化了水处理工艺流程，引入了新型膜过滤技术和在线监测设备，显著提升了水质控制水平。同时，通过制定标准化的验证方案，包括安装确认（IQ）、运行确认（OQ）和性能确认（PQ），确保系统在全生命周期内的合规性。结果表明，该系统能够持续提供符合药典标准的纯化水和注射用水，且运行成本较传统系统降低约15%。此外，创新性地建立了基于大数据分析的预测性维护模型，有效减少了系统故障率和停机时间。本研究的主要贡献在于提出了集成化的设计理念和智能化的验证策略，为制药行业提供了可借鉴的技术路径，进一步推动了制药用水系统的现代化发展。
关键词：制药用水系统；风险评估；膜过滤技术；验证流程；预测性维护模型
Abstract
Pharmaceutical water systems, as a critical component in the drug manufacturing process, directly influence the quality and safety of pharmaceutical products. This study, based on current GMP regulatory requirements and aligned with practical production needs, aims to develop a scientific and efficient design scheme for pharmaceutical water systems while ensuring their stability and reliability through systematic validation procedures. By employing risk assessment methodologies, the study conducts a comprehensive analysis of system design, optimizes water treatment processes, and incorporates advanced technologies such as novel membrane filtration and online monitoring equipment, thereby significantly enhancing water quality control. Standardized validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), are established to ensure compliance throughout the system’s lifecycle. Results demonstrate that the system consistently delivers purified water and water for injection meeting pharmacopeia standards, with operational costs reduced by approximately 15% compared to traditional systems. Additionally, an innovative predictive maintenance model based on big data analytics is developed, effectively minimizing system failure rates and downtime. The primary contribution of this research lies in proposing an integrated design philosophy and intelligent validation strategies, offering a replicable technical approach for the pharmaceutical industry and further advancing the modernization of pharmaceutical water systems.
Keywords：Pharmaceutical Water System; Risk Assessment; Membrane Filtration Technology; Validation Process; Predictive Maintenance Model
目 录
摘要 I
Abstract II
一、绪论 1
(一) 制药用水系统研究背景与意义 1
(二) 国内外研究现状分析 1
(三) 本文研究方法与技术路线 2
二、制药用水系统的设计原则与规范 2
(一) 制药用水系统的分类与功能需求 2
(二) 设计依据与相关法规标准 3
(三) 系统设计的关键技术参数 3
(四) 设计中的风险评估与控制 4
三、制药用水系统的验证流程与方法 4
(一) 验证的基本概念与重要性 4
(二) 验证方案的制定与实施 5
(三) 关键性能指标的测试与分析 5
(四) 验证结果的评估与改进 6
四、制药用水系统的运行管理与维护 6
(一) 系统运行中的质量监控策略 6
(二) 日常维护的技术要求与规范 7
(三) 故障诊断与应急处理机制 7
(四) 持续改进与生命周期管理 8
结 论 9
参考文献 10
