Calibration Programs Required by Regulatory Authorities

Author: Kenneth Christie
Calibration is the comparison of two instruments or measuring devices one of which is a standard of known accuracy (traceable to national standards) to detect, correlate, report or eliminate by adjustment, any discrepancy in accuracy of the instrument measuring device being compared to the standard.
Calibration & Preventative Maintenance
Any equipment, including computers that could perform a function satisfactorily, and could be used in the manufacturing, processing, packing, and also holding of a drug product must be routinely calibrated as per a written program designed to guarantee proper performance. Written records of such calibration checks shall be maintained.
Instrument / Equipment Master List
Instrument/Equipment Master List is a system for detection of all instrumentation related to GMP in a manufacturing area or laboratory. It includes instrumentation details such as model number, serial number & location). Procedures should spot the maintenance and calibration requirements for all equipment on the master list.
Instrument Identification & Calibration Status
Under instrument identification & calibration status each instrument will be given a unique identifier. Instrumentation details related to this number requires to be documented. All equipment must be labeled with the unique identifier. Calibration status and the date of calibration of all instruments must be made available. There should be a system in place to prevent use of an equipment that is not qualified.
Calibration Requirements
The Calibration requirements for Laboratory Instruments under the US Code of Federal Regulations, 21 CFR 211.67 includes, schedules, specific directions, limits of accuracy & precision, corrective actions, systems to stop instrument usage failing calibration.

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