Why is Mandatory to Calibrate the Measurement Instruments?

In this article, you will learn why is mandatory to calibrate the measurement instruments and gauges according to the ISO 17025 Testing and Calibration Laboratories and FDA requirements.

Government regulations require that FDA regulated companies bring calibration to their instruments and equipment to assure their confidence and reliable results.

Some industries work under stricter calibration requirements due to the type of product and process.

Failing to comply with the calibration requirements, can cause fines, loss of business, or damage to a business’s reputation.

Moreover, the cGMP current Good Manufacturing Practices and the QSR Quality System Regulations mandate to establish a reliable calibration program.

In addition, the CMS calibration management system serves as a registry log book and tracking system of all calibration in the chronologic order that was done. It helps to bring the evidence that calibration has been done to each instrument by date during its life cycle.

Consequences to not perform an adequate calibration on-time?

Failure to adhere to proper calibration delivery is considered a violation of US Federal regulations on GMP Good Manufacturing Practices. As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to bring calibration, and failed to design and implement an effective calibration control program or management system either manual or electronic.  In some cases, it may result in an FDA warning observation, product hold, product recall, etc.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES:

For more information about why is mandatory to calibrate the measurement instruments, refer to:

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

PART 820 — QUALITY SYSTEM REGULATION

Subpart G–Production and Process Controls

Sec. 820.72 Inspection, measuring, and test equipment.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.72

ISO/IEC 17025 TESTING AND CALIBRATION LABORATORIES

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.

ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.

httpss://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html

TITLE 21–FOOD AND DRUGS

PART 111 — CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS – Calibration Management System

Subpart D–Equipment and Utensils

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=111.35

21 CFR § 58.63 – Maintenance and calibration of equipment.

• 58.63 Maintenance and calibration of equipment.

httpss://www.law.cornell.edu/cfr/text/21/58.63

40 CFR § 160.63 – Maintenance and calibration of equipment.

• 160.63 Maintenance and calibration of equipment.

httpss://www.law.cornell.edu/cfr/text/40/160.63

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