Metrohm 828 IC Dual Suppressor - Manual (Page 53)

6.4 Validation / GLP
828 IC Dual Suppressor/ 8.828.1003 Instructions for Use
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6.4 Validation / GLP
GLP (Good Laboratory Practice) requires, among other things, that the
precision and correctness of analytical instruments is checked at
regular 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 Chromatography Systems by using
Standard Operating Procedures (SOP)». This SOP can be adapted
for your ion chromatography system and used for its validation.
The 828 IC Dual Suppressor must be included as a part of the whole
ion chromatography system, whose most important components
include the pumps, separation 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 828 IC Dual Suppressor. It can also provide you with
validation 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
obtainable from your local Metrohm agency.
Checking the electronic and mechanical assemblies of Metrohm
instruments can and should be undertaken within the framework of
regular servicing by Metrohm technicians (see Section 5.2). All Metrohm
instruments are equipped with start-up check routines which check that
the relevant assemblies are functioning perfectly when the instrument is
switched on. If no error message appears it can be assumed that the
instrument is functioning properly.
The 828 IC Dual Suppressor also contains a built-in diagnosis program
which allows the service technicians to check the functioning of
particular assemblies should faults or malfunctions occur and to
localize them.