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4 validation / glp, Validation / glp – Metrohm 830 IC Interface User Manual

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4 Appendix

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 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

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