CAJ | 학술논문

通过验证组织机构的建立、人员职责确定、验证前准备、温湿度布点位置和数量的确定以及数据收集、分析等几方面内容,设计药品仓储区温湿度分布的验证;通过验证的实施,确认仓储区能达到药品储存的温湿度条件要求,同时确定库区内温湿度的极端状态,为仓储区温湿度的日常检查和监控提供科学依据.
통과험증조직궤구적건립、인원직책학정、험증전준비、온습도포점위치화수량적학정이급수거수집、분석등궤방면내용,설계약품창저구온습도분포적험증;통과험증적실시,학인창저구능체도약품저존적온습도조건요구,동시학정고구내온습도적겁단상태,위창저구온습도적일상검사화감공제공과학의거.
Design the mapping validation for temperature and humidity of warehouse from the following factors: establishing validation organization, confirming the staff responsibility, preparing before validation, setting locations of the mapping points and quantity, collecting data and carrying out analysis, etc. Validation can ensure the temperature and humidity meet the medicinal storage requirements and find the extremes condition in the warehouse to provide the reference for daily monitoring and checking.