Importance of Calibration

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Importance of Calibration

PHARMACEUTICAL (FDA, U.S. Food and Drug Administration) Any pharmaceutical company that sells their products in the USA must comply with FDA regulations, regardless of where the products are manufactured.
• Calibration records must be maintained.
• Calibrations must be done in accordance with written, approved procedures.
• There should be a record of the history of each instrument.
• All instrumentation should have a unique ID; all product, process and safety instruments should be physically tagged.
• A calibration period and error limits should be defined for each instrument.
• Calibration standards should be traceable to national and international standards.
• Calibration standards must be more accurate than the required accuracy of the equipment being calibrated.
• All instruments used must be fit for purpose.
• There must be documented evidence that personnel involved in the calibration process have been trained and are competent.
• Documented change management system must be in place.
• All electronic systems must comply with FDA’s 21 CFR Part 11.

• All of the above should be implemented in conjunction with following regulations: – 21 CFR Part 211 – “Current Good Manufacturing Practice for Finished Pharmaceuticals” – 21 CFR Part 11 – “Electronic Records; Electronic Signatures”

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