摘要
本研究聚焦广东星昊药业有限公司的GMP文件管理体系,综合运用文献研究、案例分析等方法深入剖析。首先阐述GMP文件管理的框架基础,明确其在药品质量保证体系中的核心地位。深入分析药品委托生产文件管理体系的关键环节,发现体系运行虽在规范操作、保障质量和满足合规方面取得一定成效,但存在质量信息沟通制度未建立或不明确、文件审核不细致等问题。针对这些问题,从流程优化、人员管理强化和信息技术应用升级三个维度提出优化策略,旨在提升企业GMP文件管理水平,保障药品质量,为药品生产企业提供实践参考和借鉴,推动行业GMP文件管理体系的完善与发展。
This study focuses on the GMP document management system of Guangdong Sunho Pharmaceutical Co.,Ltd.,and conducts an in-depth analysis by comprehensively using methods such as literature research and case analysis.Firstly,it expounds the framework basis of GMP document management and clarifies its core position in the pharmaceutical quality assurance system.By deeply analyzing the key links of the document management system for entrusted pharmaceutical manufacturing,it is found that although the system operation has achieved certain results in standardizing operations,ensuring quality,and meeting compliance requirements,there are still some problems,such as the absence or ambiguity of the quality information communication system and the lack of meticulousness in document review.In response to these issues,optimization strategies are proposed from three dimensions:process optimization,personnel management strengthening,and information technology application upgrading.The aim is to improve the GMP document management level of enterprises,ensure pharmaceutical quality,provide practical references and experiences for pharmaceutical manufacturing enterprises,and promote the improvement and development of the GMP document management system in the industry.
作者
马丽
Ma Li(Guangdong Sunho Pharmaceutical Co.,Ltd.,Zhongshan 528437,China)
出处
《广东化工》
2026年第1期67-71,共5页
Guangdong Chemical Industry
关键词
委托生产
GMP文件管理
药品质量
优化策略
信息技术应用
实践参考
entrusted manufacturing
GMP document management
pharmaceutical quality
optimization strategies
information technology application
practical reference
