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Difference among Calibration, Validation & Qualification


What is Calibration and Validation, Definition of Calibration and Validation, Qualification is a part 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.

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.

Validation:

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.


Qualification:

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



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Anonymous said...

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sunil said...

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Thakur said...

thanks

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