盐酸阿柔比星冻干制剂的技术转移验证研究

Technology transfer validation of lyophilized powder for injection of aclarubicin hydrochloride

目的:考察盐酸阿柔比星冻干制剂生产技术转移的工艺可行性和质量可靠性。方法:通过制剂生产工艺验证和质量稳定性研究来评价盐酸阿柔比星冻干制剂生产技术转移的工艺可行性和质量可控性。结果:制剂生产工艺和质量分析技术转移验证结果符合中国GMP要求,并且通过了日本PMDA的GMP认证。结论:盐酸阿柔比星冻干制剂的生产工艺可行,产品质量可控。

Objective： To investigate the feasibility and reliability of the technology transfer in the preparation of lyophilized powder for injection of aclarubicin hydrochloride. Methods： The production technology transfer of the freeze dried formulation of aclarubicin hydrochloride from Japan to China was evaluated by the preparation process validation and quality stability. Results： The verification results of the production process and the quality analysis of the technology transfer were in accordance with the requirements of GMP,and passed the GMP certification of PMDA in Japan. Conclusion： The production technology transfer of lyophilized powder for injection of aclarubicin hydrochloride from Japan to China is feasible and the product quality is controllable.