| 王元,李武超,江映珠,沈波,伦得智,何文祺,谢正福.我国疫苗生产企业质量风险管理实施情况问卷调研及结果分析[J].中国药事,2022,36(10):1122-1133 |
| 我国疫苗生产企业质量风险管理实施情况问卷调研及结果分析 |
| Questionnaire Survey and Result Analysis on the Implementation of Quality Risk Management in Vaccine Manufacturers in China |
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| DOI：10.16153/j.1002-7777.2022.10.005 |
| 中文关键词: ICH Q9 质量风险管理 疫苗 药品监管 GMP |
| 英文关键词: ICH Q9 quality risk management vaccine drug regulation GMP |
| 基金项目: |
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| 中文摘要: |
| 目的：调研现阶段我国疫苗生产企业进行质量风险管理(Quality Risk Management，简称QRM) 的实际情况，为今后制定或引进适合我国实际的QRM标准、相关指南提出合理建议。方法：对ICH Q9 质量风险管理要点进行提炼，选择国内疫苗生产企业作为调查对象，以发文邮寄方式发放问卷进行调查，并对调研结果进行分析。结果：本次调研显示ICH Q9在我国疫苗生产企业适用性较高，但个别执行环节存在偏差。结论：本调研对完善我国疫苗生产过程质量风险管理提出了合理化建议。 |
| 英文摘要: |
| Objective: To carry out a survey on the actual situation of quality risk management (QRM) in vaccine manufacturers in China at present stage, and put forward reasonable suggestions for formulating or introducing QRM standards and relevant guidelines suitable for China's actual situation in the future. Methods: The key points of ICH Q9 quality risk management were refi ned, domestic vaccine manufacturers were selected as the investigation objects, and after questionnaires were distributed by post for survey, the survey results were analyzed. Results: This study shows that ICH Q9 is highly applicable to vaccine manufacturers in China, but there are deviations in implementation links. Conclusion: This survey provides reasonable suggestions for improving quality risk management in vaccine production process in China. |
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