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目的:研究探讨适合中药制剂生产企业清洁验证的方法,为同行提供可借鉴的经验。方法:结合中药制剂特点,从风险评估、设备清洁方法、设备清洁验证时机、残留物限度的确定、取样及分析方法等方面进行探讨。结论:结合中药生产特点制定可行的清洁验证方案,确保药品安全有效。
Objective: To study and explore suitable methods for cleaning validation of traditional Chinese medicine manufacturing enterprises, providing experience for their peers. Methods: Based on the characteristics of traditional Chinese medicine preparations, the methods of risk assessment, equipment cleaning methods, timing of equipment cleaning verification, determination of residue limits, sampling and analysis methods were discussed. Conclusion: Based on the characteristics of traditional Chinese medicine to develop viable cleaning validation program to ensure that drugs safe and effective.