In pharmaceutical industries, these three terms are commonly used. Sometimes there is confusion between these terms due to similar concepts but different in operation. Here I would like to explain these terms in a simple way that will be easy to understand.
Calibration, verification, and validation are three distinct concepts commonly used in various fields to ensure the accuracy and reliability of measurements, systems, and models. While they share some similarities, they differ in their purpose, methods, and outcomes. Here's a brief overview of each concept:
What is Calibration?
Calibration refers to the process of adjusting or checking the accuracy of an instrument or measurement system to a known standard or reference. The aim of calibration is to ensure that the instrument or system provides measurements that are reliable and accurate within a specified range of values. Calibration is typically done by comparing the measurement results of the instrument or system to a known reference or standard, and adjusting the instrument accordingly. Calibration is often done on a regular basis to ensure that the instrument or system remains accurate over time.
- Calibration determines if a device or instrument is producing accurate results within the specified limits compared to those produced by a traceable standard over an appropriate range of measurements.
- The act of checking or adjusting (by comparison with a standard) the accuracy of a quantitative measuring instrument.
- Calibration can be considered as a comparison between two entities, to ensure one is equal to the other, within the accepted tolerances. The entity used as a reference in the comparison is known as the standard.
- Ensure the measurement accuracy of an instrument compared to a known standard.
- Comparing against a reference standard.
- Calibration is identifying and adjusting when possibles the measurement errors of a measuring.
- Reference standard (Known standard) used in calibration.
What is Verification?
Verification is the process of checking that a product, service, or system meets the specified requirements or specifications. Verification typically involves testing or inspecting the product or system to ensure that it meets the intended design or performance criteria. The goal of verification is to ensure that the product or system functions as intended and meets the user's needs. Verification is often done during the design and development phase of a product or system.
- Verification is the comparison of results against specifications.
- Checking standard process.
- Reviewing, inspecting or testing the process.
- Ensure the correct operation of equipment or a process according to its stated operating specification.
ALSO READ: SOP for Operational Qualification
What is Validation?
Validation is the process of testing or evaluating a product, service, or system to ensure that it meets the user's needs and requirements. Validation typically involves testing the product or system under real-world conditions or scenarios to ensure that it performs as expected and meets the user's needs. The goal of validation is to ensure that the product or system meets the intended purpose and satisfies the user's expectations. Validation is often done after the product or system has been developed and before it is released to the market or used in a real-world setting.
- Validation is the procedure of establishing documented evidence that provides a high degree of assurance that the specific process will consistently produce a product meeting its predetermined specification and quality attributes.
- Documenting that a process or system meets its predetermined specification and quality attributes.
- Ensure that a system satisfies the stated functional intent of the system.
- No reference standards are required in the validation program.
- Validation provides documented evidence that a process, equipment method or system produces consistent results.
Difference between Calibration and Validation
In summary, calibration ensures the accuracy of an instrument or measurement system, verification checks that a product or system meets the intended design or performance criteria, and validation tests a product or system to ensure that it meets the user's needs and expectations.
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