GMP,药品,药学,制药,新药,色谱,药品生产,中药,药材,原料药,医药,中间体,药用辅料

高效液相色谱仪检定

时间: 2012-04-03 15:21:01 作者: 来源: 字号:
请教:高效液相色谱仪每半年自检检定工作大家都做什么项目,如何做啊?




流速,流量,压力,保留时间等,
请使用相关搜索工具弄一下,据说一堆
然后根据自己的实际情况制定流程




搜搜只有一个,百度文库和豆丁都是同一个




http://wenku.baidu.com/search?word=HPLC%C9%AB%C6%D7%D2%C7%BC%EC%B6%A8%B9%E6%B3%CC+%D2%BA%CF%E0&lm=0&od=0




http://analysis.dxy.cn/bbs/thread/14108112
EDQM的指南可以参考:

· UPDATED:Qualification of Equipment (core document)
PA/PH/OMCL (08) 732R (July 2011)

· UPDATED: Annex 1:Qualification of HPLC Equipment
PA/PH/OMCL (11) 04(July 2011)

· Annex 2:Qualification of GC equipment
PA/PH/OMCL (06) 86DEF (October 2006)

· Annex 3:Qualification of UV-Visible spectrophotometers
PA/PH/OMCL (07) 11DEF CORR (December 2007)

· Annex 4:Qualification of IR spectrophotometers
PA/PH/OMCL (07) 12DEF CORR (December 2007)

· Annex 5Qualification of Automatic Titrators
PA/PH/OMCL (07)108 3R Qualification of equipment (August 2008)

· Annex 6:Qualification of piston pipettes
PA/PH/OMCL (09) 642R, Annex 6: Qualification of piston pipettes (July 2010)

· NEW: Annex 7Qualification of mass spectrometers
PA/PH/OMCL (10) 862R (July 2011)

· Validation ofComputerised Systems - Core Document
PA/PH/OMCL (08) 693R (July 2009)

· Annex 1:Validation of computerised calculation systems: example of validation ofin-house software
PA/PH/OMCL (08) 872R Validation of Computerised Systems (July 2009)

· Annex 2:Validation of Databases (DB), Laboratory Information Management Systems (LIMS)and Electronic Laboratory Notebooks (ELN)
PA/PH/OMCL (08) 88R Validation of Computerised Systems (July 2009)

· Annex 3:Validation of computers as part of test equipment
PA/PH/OMCL (08) 89R Validation of Computerised Systems (July 2009)

· Archiving withinthe OMCL Network
PA/PH/OMCL (07)105 DEF (April 2001)




谢谢楼上各位!
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