Validation is documented evidence that gives assurance that a process will consistently produce a product with pre-defined specifications and quality. Validation is documented proof that a process, procedure, or activity will produce the same results in testing and production.
Validation is the requirement of the FDA and other regulatory bodies that demand that not only the products manufactured should be of high quality but all the procedures for manufacturing and the testing should be of high quality to produce the same results.
Validation gives assurance that in a pharmaceutical industry, a product produced is of good quality and is fit to use and the same product will be produced when repeating the specific written methods or procedures.
The concept of validation was first introduced by the FDA in 1979 to improve product quality.
Calibration is the activity that demonstrates that the results produced by the instrument or a device are within range of the standard unit.
Calibration is used to define the accuracy,range and precision of the device.
Difference Between Validation and Calibration
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