6 glp validation, Glp validation – Metrohm 824 Easy Sample Changer User Manual

Page 42

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5.2 Care / Maintenance

36

824 Easy Sample Changer,

GLP validation

6 GLP

validation

Each Metrohm instrument undergoes a rigorous quality control process

before dispatch.

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 Procedure, SOP).

As this instrument is not an analytical instrument as such, we recom-

mend the user to include the 824 Easy Sample Changer as part of an

analytical system in its all-embracing validation.

If the sample changer is primarily used for titrations then the validation

of the titrator is best carried out by using the sample changer. In this

way any interference (e.g. carryover of titrant or sample solution), which

could influence the results obtained, in 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 it can be assumed that the instrument is

functioning properly. Metrohm also supplies the instruments with built-in

diagnosis programs which allow the service technicians to check the

functioning of particular assemblies should faults or malfunctions occur

and to localize them.

Recommended literature

Metrohm booklets "Quality management with Metrohm"; detailed in-

formation about the principles and methods of Good Laboratory

Practice

Metrohm Application Bulletin 252/1 "Validation of Metrohm titrators

according to GLP/ISO 9001"

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