4 validation / glp, Validation / glp – Metrohm 816 IC Eluent Selector User Manual
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4.4 Validation / GLP
4.4
Validation / GLP
GLP (Good Laboratory Practice) requires, among other things, that the
precision and correctness of analytical instruments is checked at regu-
lar intervals by using SOPs (Standard Operating Procedures, SOP). An
example of such a standard operating procedure is available from
Metrohm under the title «Application Bulletin No. 277 – Validation of
Metrohm Ion Chromatographs». This SOP can be adapted for your
ion chromatography system and used for its validation.
The 816 IC Eluent Selector must be included as a part of the whole ion
chromatography system, whose most important components include
the pumps, separating columns, detector and evaluation system, in the
all-embracing validation of the whole system.
Please contact your local Metrohm agency in order to receive support in
validating your 816 IC Eluent Selector. It can also provide you with vali-
dation documentation which will help you to carry out your installation
qualification (IQ) and operational qualification (OQ).
Further information about QA, GLP and validation can also be found in
the brochure «Quality Management with Metrohm» which is also ob-
tainable from your local Metrohm agency.
Checking the electronic and mechanical assemblies of Metrohm in-
struments can and should be undertaken within the framework of regu-
lar servicing by Metrohm technicians.
816 IC Eluent Selector/ 8.816.1003 Instructions for Use
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