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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 washout the confusion. I think it will make a clear image about these three concepts and their definitions.


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


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.

Related: Validation in Pharmaceutical Manufacturing


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.

Also see: Water for Injection (WFI) System 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.
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Anonymous said... on 17/4/11 22:24

Your updates are good keep it up.

sunil said... on 17/4/11 22:49

send updates on GMP

Thakur said... on 25/1/14 22:29


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