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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 consistency of quality before and after the change of sterile water for injection by comparability analysis. Methods The methods of risk assessment were used to analyze the materials, plant facilities, personnel and production technology before and after the change of the production site of sterilized water for injection. The results of the product quality parameters and the stability test were statistically analyzed. As a result, it was confirmed that the materials and personnel before and after the change of the production site of the sterilized water for injection were the same, and the facilities and production processes of the plant were confirmed to be changed. Three batches of listed sterilized water for injection were verified after the change. There was no significant difference in the test results of p H, conductivity, and non-volatiles among the three batches of products continuously produced after the change of production sites and the two consecutive years of production of sterile water for injection prior to the change (P> 0.05); 3 Batch sterilized injection water accelerated stability test within 6 months p H 5.0 ~ 7.0, conductivity ≤ 25μS / cm (25 ℃), non-volatile matter ≤ 1 mg. Conclusion The quality of sterilized water for injection was the same before and after the change, both of which met the standards of the second part of Chinese Pharmacopoeia (2010 edition).