关于医疗机构制剂设备验证的必要性及方法探讨

目的:将验证理念引入医疗机构自制制剂设备。方法:从医疗机构自制制剂的特殊性、制剂设备的现状和要求等方面分析医疗机构制剂设备验证的必要性和难点问题。结果:提出了医疗机构制剂设备的验证范围和验证程序。结论:医疗机构一定要根据本单位的实际情况,采用适宜的方法、途径和验证程序,对不同的制剂设备开展有针对性的验证工作。

Necessity and Methods for Validation of Equipments of Preparations in Medical Institutions

OBJECTIVE： To introduce validation to the equipments of self - made preparations in medical institutions. METHODS： The necessity and difficulties for the validation of the equipments of self - made preparations in medical institutions were analyzed from aspects of the specificity of self-made preparations, the status quo of the preparation equipment as well as the requirements on the equipments etc. RESULTS： The scope and the procedures of the validation on the equipments of preparations had been presented. CONCLUSIONS： Medical institutions should adopt suitable methods, approach and validation procedures to develop corresponding validation work for equipments of preparations based on their own condition.