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.
Why Validation?
Validation is the requirement of the FDA and other regulatory bodies thatdemand 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.
History
The concept of validation was first introduced by the FDA in 1979 to improve product quality.
Calibration
Calibrationis 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
Validation
Calibration
Validation is the documented proof to show that when we will follow the specific written procedure the resultant product will be of the same quality.
Calibration is an assurance that the equipment or device which is being used will give precise results.
Validation assures the same results.
Calibration ensures precision.
Validation of the equipment is a documented guarantee that each part or component of the equipment is according to manufacturer’s specifications.
Calibration of the equipment gives assurance that results produced by each component of equipment are precise.
Validation is performed against a Validation Protocol.
Calibration is performed following a SOP.
Validation is performed when no standards are available.
Calibration is performed when reference standards are available.
Validation is used usually for process and methods.
Calibration is usually performed for measuring devices or instruments.
Validation is not repeated periodically.
Calibration is repeated periodically.
Validation isPerformed in following
Change in Process
Change in Method
Change in formulation
Calibration is performed in following
After specific time intervals mentioned by the manufacturer.
In case of shock or hit to the device.
Replacement of some part.
Change in device location.
In Validation no reference standards are available to compare.
In Calibration, values are compared with reference standards.
Validation is done by the validation team of the pharmaceutical industry.
Calibration is usually done by a third party.
Validation requires no certificate, it requires only documentation.
Calibration requires a calibration certificate.
Validation has no expiration date.
Calibration certificates have pre-defined expiration dates.
If validation fails it means the product is not fit for use.
If calibration fails it means the device is not ready to produce required results.
In validation different samples are taken at different intervals to set the standard procedure.
In calibration,a device is tested against different ranges of values.
Validation failure may be addressed by modifications.
Calibration failure may be addressed by repairing.
In validation results are acceptable after modifications and repeating the activity.
In calibration results are acceptable after repairing.
