Metrohm 789 Robotic Sample Processor XL - Manual (Page 130)

5.1 Validation / GLP
122 Metrohm Sample Processor, GLP validation – diagnosis
5 GLP validation – diagnosis
5.1 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.
As this instrument is not a measuring instrument as such, we recom-
mend that the Sample Processor is included in an analytical system
and is validated as part of the all-embracing validation of the whole
analytical system.
If the Sample Processor is primarily used for titration purposes then it is
advisable to carry out the validation of the titrator with the help of the
Sample Processor. In this way any possible interference (e.g. carryover
of titrant or sample solutions) that could influence the results is included
within the framework of the evaluation of the complete titration system.
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 the instrument is functioning properly.
Metrohm also supplies its instruments with built-in diagnosis programs
which allow the service technicians to check the functioning of particu-
lar assemblies should faults or malfunctions occur and to localize them.
Diagnosis programs can also be incorporated in a validation method.
Guidelines for drawing up standard operating procedures for checking
a titration system can be found in Application Bulletin 252/1 ("Validation
of Metrohm titrators in accordance with GLP/ISO9001"). This can be ob-
tained free of charge from Metrohm.