4 Appendix
4.4
Validation / GLP
GLP
(
G
ood
L
aboratory
P
ractice) requires, among other things, that the
precision and correctness of analytical instruments is checked at regu-
lar intervals by using SOPs (
S
tandard
O
perating
P
rocedures,
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 Oper-
ating Procedures (SOP)»
. This SOP can be adapted for your ion
chromatography system and used for its validation.
The 830 IC Interface must be included as a part of the whole ion chro-
matography 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 830 IC Interface. It can also provide you with validation
documentation which will help you to carry out your installation qualifi-
cation (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. All Metrohm instruments are
equipped with start-up check routines which check that the relevant as-
semblies 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 830 IC Interface also contains a built-in diagnosis program which
allows the service technicians to check the functioning of particular as-
semblies should faults or malfunctions occur and to localize them.
830 IC Interface / 8.830.1003 Instructions for Use
40
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