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Thursday, January 5, 2012

Difference among calibration, validation & qualification

Difference 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.

2 comments:

  1. ADB Consulting provides custom automated equipment that we tailor for each client?s specific needs. We design, program, and build automated equipment for use in a variety of sectors, including research and development, manufacturing, and quality control. We also offer printed circuit board (PCB) assembly, High-Level Architecture Integration (HLA), contract manufacturing, and validation services for equipment, software, and processes.

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  2. A lot of pharmaceutical professionals are having a big confusion among calibration, validation and qualification, hence I am trying to washout the confusion. NDT calibration products

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