All You Need to Know About GMP Calibration Management System.

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

WHAT IS A CALIBRATION?

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.

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.

As per 21 CFR part 820.72:

“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.”

WHAT IS A CALIBRATION MANAGEMENT SYSTEM CMS?

A Calibration Management System is the program designated to handle your entire calibration operation.

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.

WHAT IS A CALIBRATION STANDARD?

Calibration standards are known as reference standard instruments typically with 3 or more times more accuracy than the instruments that will be calibrated with.  Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards (NIST Traceable calibrations. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.

WHAT IS CALIBRATION CERTIFICATE OR CALIBRATION RECORD?

Calibration records are commonly known as calibration certificates contain the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date. In addition to the calibration certificate, a calibration tag or label is placed or displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.  These calibration tags typically contain:

• equipment identification
• calibration date
• next calibration date

WHAT IS THE FREQUENCY OF YOUR INSTRUMENT’ CALIBRATION?

Many federal regulations and company policies require to comply with specific 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.

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

WHEN IS NECESSARY A CALIBRATION?

Calibration is needed whenever an instrument is added or modified in the manufacturing process, procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc.

More specifically, a calibration must be considered if you add, modify, or impact any instrument or equipment related to the measurement in the following areas:

• Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
• Packaging or labeling information, process, or materials.
• The shelf life of raw material, components, or finished products
• Process parameters
• Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
• Equipment or equipment settings
• Qualified cleanrooms
• Cleaning processes of the manufacturing environment or manufacturing equipment
• Facilities or utilities
• Locations for manufacturing, testing, sterilization, or warehousing
• Environmental conditions of manufacturing, testing, or storage,
• Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
• Suppliers or external manufacturers
• Line re-configuration as it relates to operators changing from a seated to standing position, updates to the line and station layouts, or re-sequencing of process steps
• Throughput time as it relates to changes to the material storage time between processes
• Product handling techniques as it relates to material storage and conveyance
• Working with multiple lots at different stations.
• Layouts in areas of product handling like manufacturing and warehouse
• Any change that can potentially impact form, fit, or function and the quality of the product.
• Changes related to supplied items, raw material, components, or finished products in regards to:
  • manufacturing or assembly processes
  • control or monitoring processes
  • cleaning processes
  • product handling
  • inspection or release processes
  • configuration check inspections
  • sample size or sampling plans
  • method of testing (e.g. physical, analytical, microbiological)
  • packaging or labeling processes
  • sterilization process
  • storage, shipment, or distribution processes.

WHY IS MANDATORY TO CALIBRATE?

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 GMP and the QSR mandate to establish a reliable calibration program.

In addition, the 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 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.

HOW TO FILL A CALIBRATION RECORD FORM?

A calibration certificate may include, but, is not limited to complete the following sections and information related to the calibration provided to the instrument, (as applicable)

• Calibration number:
• Version
• Reason and Description of the Calibration.
• Related Topics, Documents or Procedures.
• What is included in the calibration?
• Why is the calibration provided / justification?
• How was the calibration performed?
• Where was the calibration done?
• When was the calibration done?
• Calibration Duration
• Calibration Type categorization
• Impacted areas of the calibration and documents affected.
• Calibration requirements
• Calibration Execution Description
• Actual results, standard results, deviation evaluation, adjustment calibration implementation completion & calibration approval,
• Calibration status, pass or fail.
• Calibration performed by name and signature, date
• Calibration reviewer name and signature, date

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 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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