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1. Regulatory requirements
Written standards or other quality documents stipulate that equipment used to produce analytical results must be qualified, maintained, calibrated and checked at defined time intervals, and that test results must be documented. Equipment must be "qualified", which means "fit for purpose".
For the pharmaceutical industry, equipment qualification is not a new concept; requirements and recommendations are mentioned in :
Good Manufacturing Practice (GMP) in Europe: "Measuring, weighing, recording and control equipment must be calibrated and checked at defined intervals, using appropriate methods. Records of these methods must be kept" ...
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Regulatory requirements
Terminology
Bibliography
Standards and norms
- Calibration and verification procedure for non-automatic weighing instruments (IPENA) – Part 1: verification - FDX 07-017 - 1995
- Maintenance – Maintenance terminology - NF EN 13306 - 2010
- Geometric product specification (GPS) – Verification by measurement of parts and measuring equipment – Part 1: Decision rules for proving compliance or non-compliance with the specification - NF EN ISO 14253-1 - 2013 ...
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Organizations
French Standards Association (Afnor) http://www.afnor.org/
ASTM International http://www.astm.org/
Eurachem http://www.eurachem.org/
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