中国药业2025，Vol.34Issue(11)：18-22,5.DOI:10.3969/j.issn.1006-4931.2025.11.005
长江三角洲地区制药企业药品包装材料应用现状调研分析
Investigation and Analysis of the Current Application of Pharmaceutical Packaging Materials in Drug Manufacturing Enterprises in the Yangtze River Delta Area
摘要
Abstract
Objective To improve the quality control and management level of pharmaceutical packaging materials(PPM)in drug manufacturing enterprises.Methods The questionnaire survey,online survey(phone,email,etc.),on-site survey,and interviews were conducted to investigate the overview,the use of PPM,and the main problems faced in the quality control and management of PPM in 38 drug manufacturing enterprises in the Yangtze River Delta Area of China,and targeted suggestions were put forward.Results Among the 38 drug manufacturing enterprises in the Yangtze River Delta Area,the main enterprises were private enterprises(16 enterprises),with the highest number of drug manufacturing enterprises(20 enterprises)producing chemical drugs,15 drug manufacturing enterprises produced oral preparations by using low-risk PPM,while 23 drug manufacturing enterprises produced injections and inhalation preparations by using medium-to-high-risk PPM.A total of 12 drug manufacturing enterprises(31.58%)have used imported PPM in their production processes,and the main types of PPM used were plastic(35.90%),rubber(23.08%),and glass(23.08%).The main quality problems of PPM were poor quality uniformity(22.22%)and insufficient or unstable supply(26.67%).Drug manufacturing enterprises mainly considered quality stability(35 enterprises)and supply chain stability(33 enterprises)when choosing PPM.The main problems facing the quality control and management of PPM were insufficient inspection and research capability.Conclusion It is recommended that drug manufacturing enterprises should enhance the quality control awareness of PPM,strengthen the research ability of policies and regulations,research ability of PPM,management ability of suppliers and cooperation and communication with PPM enterprises.It is recommended that relevant government departments should improve the construction of information sharing platforms for PPM and open effective channels for feedback,increase policy promotion and training guidance efforts.关键词
长江三角洲地区/制药企业/药品包装材料/质量控制Key words
Yangtze River Delta Area/drug manufacturing enterprises/pharmaceutical packaging materials/quality control分类
医药卫生引用本文复制引用
胡光南,徐俊,周亚菊..长江三角洲地区制药企业药品包装材料应用现状调研分析[J].中国药业,2025,34(11):18-22,5.基金项目
2023年上海市药品监督管理局专项课题[ZX-2023-04]. （）
