What is Calibration Management System CMS as per cGMP?

In this article, you will learn what is Calibration Management System CMS according to the FDA requirements.

The Calibration Management System is the program designated to handle your calibration operations and activities related to your whole company as required by Good Manufacturing Practices GMP.

It is used by regulated industries to demonstrate compliance with the calibration requirements.

It will manage the calibration requirements, sections, and calibration records.

Moreover, it organizes calibration works, schedules, calibration delivery, grading, records, and history.

A calibration management system is a program either manual or electronic intended for the administration, documentation, tracking, and reporting of instrument calibration works. Some companies use dedicated software for this purpose, other companies handle their calibration management system more manually using handwriting and hard copies.

The calibration management process includes managing and maintaining calibration records of the organization’s equipment and instruments.

A CMS manages calibration administration, instrument registration, tracking, effective monitoring, and reporting. In some cases, they are capable to manage financial aspects, including budget forecasting and cost-tracking.

WHAT KINDS OF CALIBRATION MUST YOUR ORGANIZATION ACCOMPLISH?

Even though calibration is an activity for many industries in general, this article aims specifically to the GMP calibration process necessary and required by the FDA and the QMS Quality Management System.

Sometimes initial calibration is followed by a requirement of additional recurrent re-calibrations within six months, or perhaps one year later.

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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To see the complete list of the most popular quality procedures templates, click here.

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REFERENCES:

For more information about what is calibration management system, 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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