What is an Instrument Calibration as per cGMP & ANSI/ISO/ASQ Q9001?

In this article, you will learn what is an instrument calibration NIST traceable according to the FDA requirements and International Standards Organization, ANSI/ISO/ASQ Q9001 Quality Management Systems — Requirements. 

CALIBRATION DEFINITION

Calibration is the process to corroborate and bring the documented evidence that a particular measuring device is working properly.

The calibration consists of comparing its measurements against a trusted reference instrument or standard (NIST calibrated standard) to check its precision, accuracy, and limits.  As a normal practice, the cGMP calibrations require to be NIST traceable.  The following picture shows an example of some reference standards used to calibrate weighing scales.

Traceability is defined as a “…measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty”.

A NIST traceable calibration means that the reference standards used to perform its instrument calibrations are in compliance with the National Institute of Standards and Technology (NIST) standards.

For medical devices, a more formal definition of what is an instrument calibration as per FDA is contained in the 21 CFR part 820.72: Inspection, Measuring, and Test Equipment:

“Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment so that its accuracy and fitness for use are maintained. These activities shall be documented.”

“Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.”

For pharmaceutical drugs, a more formal definition of what is an instrument calibration as per FDA is contained in the 21 CFR part Sec. 211.68 Automatic, Mechanical, and Electronic Equipment.

“(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.”

The International Standards Organization, ANSI/ISO/ASQ Q9001 Quality management systems — Requirements, clause 7.6a states, in part:

“Where necessary to ensure valid results, measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international standards or national measurement standards…”

Note: By definition, the traceability needs to eventually lead to an accredited lab that will be following procedures such as those set forth in ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.

Your internal calibration processes can best be guided by acquiring a copy of ANSI/NCSL Z540.3.

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 what is an instrument 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 – 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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