4 validation / glp – Metrohm 711 Liquino User Manual

Page 155

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6. Appendix

711 Liquino, Instructions for use

149

6.4

Validation / GLP

GLP (Good Laboratory Practice) requires, among other things, the regular

checking of the reproducibility and accuracy of analytical instruments based
on standard operating procedures,

SOP.


We recommend that you read the Metrohm booklet "Quality management
with Metrohm" if you require more detailed information about the principles
and methods of Good Laboratory Practice.

If the 711 Liquino is used as part of an analytical system (e.g. for sam-

pling tasks) it is recommended that the instrument is included in the
comprehensive validation of the complete system. If a complete system
is validated as such then all the interfering influences of the individual
components will be effective and also taken into account for the as-
sessment of the complete analytical system.

If the 711 Liquino is mainly used for dosing purposes it is recommended

that the dosing units used are checked with the aid of the GLP mode of
the 711 Liquino. You can set the demands placed on the dosing preci-
sion and accuracy by defining individual limiting values (y-axis intercept,
slope, absolute volume error) according to your own requirements.


Checking the electronic and mechanical properties of Metrohm instruments
can and should be carried out within the framework of a regular service by
specialists from the manufacturing company. All Metrohm instruments are
provided with start-up checking routines which check that the relevant com-
ponents are functioning perfectly when the instrument is switched on. If no
error message is displayed it can be assumed that the instrument is func-
tioning properly. Metrohm also supplies its instruments with built-in diagno-
sis programs which, should a fault occur, permit the functioning of certain
internal components to be checked and the fault to be localized. Diagnosis
programs can also be integrated in a validation method.

Recommended literature

Metrohm booklet "Quality management with Metrohm"

Metrohm Application Bulletin 238/1 "Dosimat Test according to GLP/ISO"

Metrohm Application Bulletin 252/1 "Validation of Metrohm Titrators ac-

cording to GLP/ISO9001"


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