摘要
目的针对中药注射剂的特点,研讨其生产设备清洁验证的意义和方法,为中药注射剂生产企业提供建议。方法从中药注射剂的特殊性入手,结合质量风险评估的理念对制药设备清洁验证中的关键问题有针对性地进行阐述和分析。结果与结论建立一个全面、科学、严谨的清洁验证方案,是确保药品质量,保证其安全性和有效性的一个必要条件。
Objective To discuss the significance and methods of traditional Chinese medicine injection（TCMI） production equipment cleaning validation base on the characteristics,and provide suggestions to those TCMI enterprises.Methods Starting from the special nature of TCMI,and combining the concept of quality risk assessment on the key issues in the pharmaceutical equipment cleaning validation,the importance of cleaning validation was expounded and analyzed.Results and Conclusion A comprehensive,scientific and rigorous cleaning validation plan is a necessary condition to ensure the quality of injections and guarantee the safety and efficacy of injections.
出处
《中国药事》
CAS
2012年第10期1132-1135,共4页
Chinese Pharmaceutical Affairs
关键词
中药注射剂
质量风险评估
设备清洁验证
traditional Chinese medicine injection
quality risk assessment
equipment cleaning validation
