Metrohm 818 IC Pump - Manual (Page 50)

6 Appendix
818 IC Pump / 8.818.1023 Instructions for Use
44
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 818 IC Pump must be included as a part of the whole ion
chromatography system, whose most important components include
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 818 IC Pump. 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. 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 818 IC Pump 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.