Metrohm 820 IC Separation Center - Manual (Page 114)

6 Appendix
819 IC Detector / 820 IC Separation Center
106
6.4 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 Chromatography Systems by using Standard Oper-
ating Procedures (SOP)». This SOP can be adapted for your ion
chromatography system and used for its validation.
819 IC Detector and 820 IC Separation Center must be included as a
part of the whole ion chromatography system, whose most important
components include the pumps, separation columns 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 819 IC Detector and 820 IC Separation Center. 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 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.
819 IC Detector and 820 IC Separation Center 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.