| 陆维怡,蔡荣.国内外药品包装系统密封完整性研究与保障药品质量安全的思考[J].中国药事,2021,35(7):828-834 |
| 国内外药品包装系统密封完整性研究与保障药品质量安全的思考 |
| Study on Sealing Integrity of Drug Packaging System at Home and Abroad and Consideration on Ensuring Drug Quality and Safety |
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| DOI：10.16153/j.1002-7777.2021.07.015 |
| 中文关键词: 药品包装系统 密封完整性 研究与应用 |
| 英文关键词: pharmaceutical packaging system sealing integrity research and application |
| 基金项目:2019国家药典委药品标准制修订课题“药包材密封完整性测试指导原则”(编号 2019Y04) |
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| 中文摘要: |
| 目的：通过比较国内外药品包装系统密封完整性研究现有的法规和技术标准，找出我国药品包装系统密封完整性研究工作存在的问题，提出在药品管理新政下开展我国药品包装系统密封性研究工作思路。方法：归纳美国及欧盟对药品包装系统密封完整性的监管要求和技术标准的情况，对照我国的现状，发现我国目前开展密封性研究存在的问题，提出今后提高和完善的方向。结果：我国药品包装系统密封完整性研究工作已经启动，但是实践中有待进一步提高理解，尚欠缺不同测试方法相应的技术标准。结论：目前我国药品包装系统密封完整性研究的技术规范已与国际接轨。后续可进一步完善相关技术性指南，建立方法标准体系，从风险管理角度出发开展实践，进一步提高药品包装系统对药品的保护作用，保证药品质量。 |
| 英文摘要: |
| Objective: To compare regulations and technical standards on the sealing integrity of pharmaceutical packaging system at home and abroad, the problems of the research on the sealing integrity of pharmaceutical packaging system existing in our country were found, the idea of carrying out research on the sealing integrity of pharmaceutical packaging system in China under the New Drug Administration Policy was put forward. Methods: To summarize the regulatory requirements and technical standards on the sealing integrity of pharmaceutical packaging system in the United States and the European Union, compare with the current situation in China, find out the problems existing in our country, and suggest directions for future improvement and refinement. Results: The research on sealing integrity of pharmaceutical packaging system in the country has already started, but the understanding needs to be further improved in practice, and there is still a lack of corresponding technical standards for different testing methods. Conclusion: At present, the technical specifications of sealing integrity of pharmaceutical packaging system in China have been in line with international standards. In the future, relevant technical guidelines can be further improved, method standard system can be established, practices were carried out from the perspective of risk management to further improvethe protective effect of medicine packaging system and ensure the quality of medicines. |
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