目的 对疫苗产品生命周期各阶段的质量管理进行研究。方法 运用生命周期理论,阐释疫苗产品生命周期的4阶段特点,并对各阶段的质量管理关注要点进行探讨。结果 疫苗产品生命周期各阶段关注要点不同,引入期重点关注研发实验室质量管理和生产线风险识别,成长期重点关注变更事项和偏差的调查处理,成熟期重点关注趋势性指标的分析研究和数据完整性、可靠性,衰退期重点关注质量保证和产品策略改进。结论 建议根据疫苗产品生命周期各阶段特点,分别做好研发实验室质量管理和生产线风险识别、变更控制和偏差调查处理、趋势性指标分析和数据完整性与可靠性、衰退期质量保证等工作。

OBJECTIVE To study the quality management of vaccine products in each stage of life cycle. METHODS Based on life cycle theory, the characteristics of vaccines in the four phases of product life cycle was interpreted, and the key quality management skills in each phase were discussed. RESULTS Each stage of life cycle of vaccine products had different concerns. In the introduction stage, more attention should be paid to quality management of R&D labs and risk identification of production lines. In the growth stage, more attention should be paid to the investigation and handling of changes and deviations. In the maturity stage, more attention should be paid to the analysis and research of trend indicators and the date reliability and integrity. In the decline stage, more attention should be paid to quality assurance and product strategy improvement. CONCLUSION According to the characteristics of the vaccines in different stages of product life cycle, some suggestions have been put forward on the quality management of vaccines, including working hardly on laboratory quality management and identification of risk of production lines, effectively managing change control and deviation survey, analyzing trend index and data integrity and reliability, and doing well in quality assurance about decline stage.