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
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