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GMP-compliant, traceable and reproducible calibration of quality-relevant measuring systems.
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Both the reproducibility of pharmaceutical processes and the quality of resultant pharmaceuticals depend on the current status and accuracy of the manufacturing plant's measuring facility.
Calibration in line with the standards covers a comparison of a measured value with the correct value within the given conditions, including documentation of the implementation and any deviations.
Our offer:
- Consultation, implementation or personnel support in the creation of measuring point indices and lists
- Critical consideration of the measuring systems with a look at GMP relevance
- Preparation of a calibration concept with associated forms and inspections templates
- Execution of traceable and repeatable calibrations
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Our procedure:
We record and identify your quality-relevant measuring systems, ensure GMP-complaint labelling on-site and collate the relevant data in specification sheets. Experienced staffs create the necessary documentation for calibration in line with standards using proven templates or according to your wishes. In principle, calibration is done the way to be traceable and reproducible by using own calibrated and qualified measuring equipment.
You result:
GMP-compliant, traceable and reproducible calibration of quality-relevant measuring systems.
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Additional information
Gempex GmbH
Mannheim, Germany
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