Difference among Calibration, Validation & Qualification : Pharmaceutical Guidelines

Difference among Calibration, Validation & Qualification

Definition of Calibration, Qualification and Validation, Qualification and calibration are the important parts of Validation.
A lot of pharmaceutical professionals are having a big confusion among calibration, validation and qualification, hence I am trying to wash out the confusion. I think it will make a clear image of these three concepts and their definitions.


The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding is known values of a reference standard.

Difference between Qualification and Validation and CalibrationLimits for acceptance of the results of measuring should be established. Always remember any reference standard is always used in calibration.


The action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.

It can better understand that the validation is a documented evidence to and done to prove the consistency of the expected results of any process, procedure or method.


The action of proving and documenting that any premises, systems and equipment are properly installed, and/or work correctly and lead to the expected results. Qualification is often a part (the initial stage) of validation, but the individual qualification steps alone do not constitute process validation. Qualification is a part of validation.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

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6 comments: Post Yours! Read Comment Policy ▼

  1. Anonymous17/4/11 22:24

    Your updates are good keep it up.

  2. send updates on GMP

  3. Thank you so much sir.. Your information is very helpful..

  4. What is the difference among calibration, performance check and operational check?

  5. definitions are easy to understand, thank your informs!


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