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| 基于产品生命周期的疫苗质量风险管理研究 |
| Research on vaccine quality risk management based on product life cycle |
| 投稿时间：2019-05-16 修订日期：2019-10-31 |
| DOI： |
| 中文关键词: 产品生命周期 疫苗 质量风险管理 |
| 英文关键词: Product life cycle vaccine Quality risk management |
| 基金项目: |
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| 中文摘要: |
| 目的 明确产品生命周期各阶段质量风险管理重点工作及控制措施，为产品全生命周期质量风险管理提供有力保障。方法 以GMP、PIC/s GMP 附件20、ICH Q8、ICH Q9、ICH Q10、ICH Q12、WHO质量风险管理指南为基础，运用归纳总结及分析评估方法，对疫苗各产品生命周期阶段中的质量风险管理进行研究。结果 通过质量风险管理研究，明确了生命周期不同阶段中影响疫苗质量的关键因素，以满足科学和法规符合性为基础，提出具体控制措施，有效防控质量风险。结论 质量风险管理伴随疫苗产品全生命周期，任何一个阶段的质量风险管理工作都需重视并认真执行，采取科学合规的控制措施，可达到有效防控质量风险的目的。 |
| 英文摘要: |
| Objective Define the key work and control measures of quality risk management in each stage of product life cycle, so as to provide a strong guarantee for quality risk management in the whole product life cycle. Methods Based on GMP、PIC/s GMP annex 20、ICH Q8、ICH Q9、ICH Q10、ICH Q12 and the WHO guideline of quality risk management, the quality risk management in the life cycle of vaccine products was studied by using the methods of induction, analysis and evaluation。Results Through the study of quality risk management, the key factors affecting vaccine quality in different stages of the life cycle were identified. Based on the scientific and regulatory compliance, specific control measures were proposed to effectively prevent and control quality risk. Conclusion Quality risk management is accompanied by the whole life cycle of vaccine products. Quality risk management at any stage should be paid attention to and implemented carefully. Scientific and compliant control measures can effectively prevent and control quality risk. |
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