生产场地变更前后灭菌注射用水质量可比性分析  

Quality comparability of sterile water for injection before and after change of production site

作　　者：杨淼[1] 朱衍志[1] 刘东梅[1] 赵一欢[1] 蒋井明[1] 刘晓凡[1] 张静 

机构地区：[1]兰州生物制品研究所有限责任公司质量保证部甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《中国生物制品学杂志》2016年第12期1274-1279,共6页Chinese Journal of Biologicals

摘　　要：目的通过可比性分析确保灭菌注射用水生产场地变更前后质量的一致性。方法应用风险评估的方法对灭菌注射用水生产场地变更前后的材料、厂房设施、人员、生产工艺进行可比性分析,并对产品质量参数及稳定性试验的结果进行统计学分析。结果确认灭菌注射用水生产场地变更前后的材料及人员均一致,且确认厂房设施及生产工艺发生了变更,需经变更后连续3批上市规模的灭菌注射用水进行验证。生产场地变更后连续生产的3批产品与变更前连续2年生产的灭菌注射用水的关键质量指标p H、电导率、不挥发物的检定结果差异无统计学意义（P〉0.05）;3批灭菌注射用水加速稳定性试验6个月内p H为5.0-7.0,电导率≤25μS/cm（25℃）,不挥发物≤1 mg。结论灭菌注射用水生产场地变更前后质量一致,均符合《中国药典》二部（2010版）的标准。Objective To ensure the quality consistency of sterile water for injection before and after change of production site by comparability analysis. Methods Comparability analysis was performed on the raw materials,workshops, facilities, personnel and production technologies before and after change of production site of sterile water for injection by risk assessment, and the quality indexes and stability test result of product were analyzed statistically.Results The raw materials and personnel after change of production site were consistent with those before change, while the workshops, facilities and production technologies changed, which were further verified with three consecutive batches of products entering the market after the change of production site. No significant differences were observed in the key quality indexes such as p H value, electric conductivity and test result of nonvolatile matters of three batches of product after change of production site and products manufactured within 2 years before the change（P〉0.05）. The pH values of three batches of sterile water for injection within 6 months after accelerated stability test were 5. 0 - 7. 0, while the electric conductivities were not more than 25 μS / cm（25 ℃）, and the nonvolatile matter contents were not more than1 mg. Conclusion The quality of sterile water for injection was stable before and after change of production site, which met the requirements in Chinese Pharmacopoeia（Volume Ⅱ, 2010 edition）.

关 键 词：生产场地变更 灭菌注射用水 可比性分析 

分 类 号：R392.33[医药卫生—免疫学]