3 glp - validation, Glp - validation – Metrohm 807 Dosing Unit User Manual

Page 44

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4.3 GLP - Validation

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807 Dosing Unit

are also available on the subject, which also contain Standard Operat-
ing Procedures
(SOP) for testing analytical measuring instruments for
reproducibility and correctness.

Maintenance
Electronic and mechanical functional groups in Metrohm instruments can
and should be checked as part of regular maintenance by specialist per-
sonnel from Metrohm. Please ask your local Metrohm agent regarding the
precise terms and conditions involved in concluding a corresponding
maintenance agreement.

NOTE

You can find information on the subjects of quality management, vali-
dation and maintenance as well as an overview of the documents cur-
rently available at

www.metrohm.com/com/

under Support.

4.3

GLP - Validation

Every dosing unit manufactured by the Metrohm company is subjected to
rigorous quality controls prior to shipment. Every dosing unit is issued a
quality certificate attesting to conformance with the strict quality criteria
of Metrohm GLP(Good Laboratory Practice) requires, among other
things, periodic inspection of analytical measuring devices with respect to
precision and correctness on the basis of standard operating procedures
Standard Operating P rocedure, SOP). This may also include an inspec-
tion of dosing accuracy.

Recommended literature

Metrohm brochure "Quality management with Metrohm", detailed
information concerning the principles and procedural methods of
Good Laboratory Practice

Metrohm Application Bulletin 283/1 "Validation of Metrohm burets"

The validation of burets is carried out by the Metrohm-Service with a spe-
cial software.

The Metrohm agents worldwide offer the possibility of on-site inspections
and certifications of dosing units and Dosinos with respect toaccuracy. It is
recommended that an accuracy inspection be performed when the dosing
cylinders and dosing pistons of a dosing unit are replaced.

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