ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Calibration

Ensuring continuous adequate performance of sensing, measurement, and actuating equipment with regard to specified accuracy and precision requirements.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Accuracy Bias Precision

Calibration

A comparison of a measurement standard or instrument of unknown accuracy to detect, correlate, report, or eliminate by adjustment of any variation in the accuracy of the unknown standard or instrument.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Calibration

(ICH Q7) The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

Calibration

(ISO) The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values of a quantity realized by a reference standard.

Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Publication Date: 2008

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