Differences between Calibration, Verification and Validation

In pharmaceutical industries, these three terms are commonly used. Sometimes there is a confusion between these terms due to similar concept but different in operation. Here I would like to explain these terms in a simple way which will be easy to understand.

What is Calibration?
  • 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 measurements accuracy of an instrument compared to an 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 comparison of results against specifications.
  • Checking standard process.
  • Reviewing, inspection or testing the process.
  • Ensure the correct operation of equipment or a process according to its stated operating specification.

What is Validation?
  • Validation is the procedure of establishing documented evidence that provide 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 standard are required in validation programme.
  • Validation provides documented evidence that a process,equipment method or system produces consistent results.

Difference between Calibration and Validation

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