制剂室药品生产偏差管理

摘要

Objective To improve the production quality of drug , so as to maximize the protection of pub-lic safety.Methods The drug production process deviation was analyzed in preparation room , and countermeas-ures were proposed .Results The main problems were as the lack of understanding of the deviation management , weakness of deviation management training , unreasonable deviation management program , and not comprehensive preventive measures .Conclusion The measures of deviation management were proposed as to improve the under-standing of deviation management , strengthen management training , and establish scientific deviation management program.%目的：提高药品生产质量水平，从而最大程度地保障公众用药安全。方法通过分析制剂室生产药品过程中偏差处理管理存在的问题，提出有效的管理建议。结果制剂生产过程中偏差管理存在的问题：对偏差管理认识不足；偏差管理培训不到位；偏差管理程序制定不合理；纠正预防措施不全面等。结论制剂生产单位偏差管理建议：提高偏差管理认识；加强偏差管理培训建立科学的偏差管理程序。