Difference Among Calibration, Validation, Qualification
Uploaded by
Dharmesh PatelDifference Among Calibration, Validation, Qualification
Uploaded by
Dharmesh PatelDifference among calibration, validation & qualification
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.
