药品检测机构仪器设备计量分类管理模式的建立及应用

Establishment and Application of Metrology-Classified Management Model of Equipment and Instruments in Drug Testing Organizations

目的初步建立药品检测机构仪器设备计量分类管理模式。方法根据国内外法律法规对设备计量的要求,结合药品检测机构仪器设备的特点,首次提出将药品检测机构仪器设备分为必须计量、选择性计量和不需要计量3种类别,针对不同类别设备提出具体的计量管理方法。结果与结论初步建立药品检测机构仪器设备计量管理模式并应用于实践,为药品检测机构仪器设备计量规范化管理提供依据。

Objective To preliminarily establish a metrology-classified management model of instruments in drug testing organizations. Methods It was the first time that instruments were categorized into three kindsequipment and instruments that must be measured, to be selectively measured and with no need of measuring. The category was made according to domestic laws and regulations on the device measurement requirements and equipment features. Specific methods of measurement management were proposed for different categories of equipment and instruments. Results and Conclusion The metrology-classified management model of equipment was established and used in practice, which provided the basis of standardized management.