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.
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 is 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.
Limits for acceptance of the results of measuring should be established. Always remember any reference standard is always used in calibration.Validation:
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.
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:
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.
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Your updates are good keep it up.
ReplyDeletesend updates on GMP
ReplyDeleteThank you so much sir.. Your information is very helpful..
ReplyDeleteWhat is the difference among calibration, performance check and operational check?
ReplyDeletedefinitions are easy to understand, thank your informs!
ReplyDeletePharma guideline is one of the trusted and accurate source of information foreveryone.
ReplyDeleteIts very valuable resources for all pharma relevant personnel. Thanks
ReplyDeleteGreat content sir g✌️
ReplyDeleteGood content.
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