How to Determine the Frequency of the Instrument’s Calibration?

In this article, you will learn what shall be the frequency of the instrument’s calibration according to the FDA requirements.

Many federal regulations and company policies require to comply with a specific frequency of the instrument’s calibration, schedules, control of calibration standards, view completion dates, test results, and detailed information such as accuracy, precision, duration of actual calibration time, or frequency.

Typically, each company establishes its own frequency of the instrument’s calibration based on a risk assessment using historical calibration information.  Based on this information, a recurrent frequency of the instrument’s calibration date can be generated, and certificates of calibration completion must be sent and stored in the document control file as per the Calibration Management System.

How to Determine the Frequency of the Instrument’s Calibration

Indeed, it starts typically establishing a short frequency of the instrument’s calibration in your procedures as low as 3  or 6 months for critical instruments with high risk and 6 to 12 months for non-critical instruments with moderate risk.  Then, as you have enough historical data of acceptable results and confidence in their instruments to maintain the calibration state during a prolonged period of time, you can justify the extension in the frequency of the instrument’s calibration using a progressive and conservative period of time with constant monitoring.

For example, if a particular type of instrument with a 6 months frequency of the instrument’s calibration demonstrates to maintain their calibration state consecutively during 1 year historically, then you can consider increasing their frequency of the instrument’s calibration in your procedures.

In other cases, if a particular type of instrument with a 6 months frequency of the instrument’s calibration demonstrates to fails and cannot maintain their calibration state consecutively during 6 months historically, then you can consider decreasing their frequency of the instrument’s calibration to 3 months or less.

In fact, in some extreme cases in which no historical data is available for high-risk processes (e.g. validation studies, etc) measuring critical process parameters (e.g. sterilization exposure temperature) may consider an instrument pre-calibration before use and an instrument post-calibration after use.

Conclusion

In summary, it is a never-ending monitoring process to demonstrate that your established frequency of the instrument’s calibration is supported by your historical data according to the intended use of the instrument and its risk of failure.

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 how to determine the frequency of the instrument’s calibration, 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 –frequency of the instrument’s calibration

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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