| 引用本文: | 董光辉,石雪纯,黄海波,叶明良,关晓旭,胡海培.阴凉库验证中常见问题及解决思路[J].中国现代应用药学,2019,36(11):1420-1424. |
| DONG Guanghui,SHI Xuechun,HUANG Haibo,YE Mingliang,GUAN Xiaoxu,HU Haipei.Common Problems in the Validation of Cool Warehouse and Their Solutions[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(11):1420-1424. |
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| 摘要: |
| 目的 发现药品经营企业阴凉库验证中的常见问题，找出其解决思路，以帮助药品经营企业把握阴凉库验证中的关键要素。方法 对照相关法规要求，剖析现阶段药品经营企业阴凉库验证中存在的相关问题，找出这些问题的解决思路。结果 剖析了现阶段药品经营企业阴凉库验证中存在的诸多关键问题，理清验证思路，帮助企业进一步认识验证管理。结论 将阴凉库验证实施到位，可以推动药品经营企业验证管理工作的长足发展。 |
| 关键词: 阴凉库 验证 温湿度 监测系统 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.11.023 |
| 分类号:R954 |
| 基金项目: |
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| Common Problems in the Validation of Cool Warehouse and Their Solutions |
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DONG Guanghui, SHI Xuechun, HUANG Haibo, YE Mingliang, GUAN Xiaoxu, HU Haipei
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Zhejiang CONBA Pharmaceutical Co., Ltd., Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmaceutical Technology, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To find the common problems in the validation of cool warehouse by the pharmaceutical trading enterprise, and find out how to solve them, so as to help the pharmaceutical trading enterprise to grasp the key elements in the validation of cool warehouse. METHODS According to the relevant regulations, to analyze the relevant problems in the validation of cool warehouse by the pharmaceutical trading enterprise at the present stage, and found out the solutions to these problems. RESULTS Analyzed many key problems existing in the validation of cool warehouse by the pharmaceutical trading enterprises at the present stage, and clarifing the validation ideas, so as to help the enterprises to further understand the validation management. CONCLUSION Implement the validation of the cool warehouse perfectly can promote the substantial development of the validation management of pharmaceutical trading enterprises. |
| Key words: cool warehouse validation temperature and humidity monitoring system |
