Basic description of calibration, qualification and validation
Calibration:
The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by material measure and the corresponding values of the measured. (National Conference of Standards Laboratories, NCSL RP-1, 1996).
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements. (FDA Guidance, part 7. Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients. Draft)
Qualification:
The action of proving that any equipment or process works correctly and consistently and produces the expected results. Qualification is part of, but not limited to, a validation process, i.e., installation qualification (IQ) , operation qualification (OQ) and performance qualification (PQ)
Validation
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
Calibration, qualification, validation
