3 glp - validation, Glp - validation – Metrohm 805 Dosimat User Manual

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5 Handling and maintenance

805 Dosimat

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13

Note

You can find information on the subjects of quality management, valida-
tion and maintenance as well as an overview of the documents currently
available at

www.metrohm.com/com/

under Support.

5.3

GLP - Validation

Every Dosimat and every exchange unit manufactured by the Metrohm
company is subjected to rigorous quality controls prior to shipment. Every
exchange unit is issued a quality certificate attesting conformance with the
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 pro-
cedures Standard Operating Procedure, SOP). This may also include an
inspection of dosing accuracy.

Recommended literature

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

Metrohm Applications Bulletin 283/1 Validation of Metrohm burets

The validation of burets is carried out by the Metrohm service with special
software.

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

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