The FDA first established the idea of validation in 1979 in an effort to raise product quality.
Validation is documented evidence that provides the confidence that a process will consistently result in a product with the pre-specified requirements and quality. It is a process, procedure, or action that must be validated in writing to show that it will yield the same outcomes in testing and production.
In the pharmaceutical sector, validation ensures that a product created is of high quality, and suitable for use and that the same product will be generated when following the precise stated processes or procedures again.
On the other hand, calibration is the process of calibrating an instrument or equipment to show that the data it produces is within the tolerances of the reference unit. The device's accuracy, range, and precision are determined by calibration.
Difference Between Validation and Calibration
| VALIDATION | CALIBRATION |
| Validation is the documented evidence that demonstrates the end product will be of the same quality when we adhere to the detailed specified procedure. | Calibration ensures that the tool or instrument being used will produce accurate results. |
| Validation guarantees the same outcomes. | Precision is ensured by calibration. |
| A verified assurance that each part or component of the equipment is in accordance with the manufacturer's standards is known as equipment validation. | Equipment calibration ensures that the findings generated by each individual piece of equipment are accurate. |
| A validation protocol is used to perform the validation. | An SOP is followed for calibration. |
| When there are no standards available, validation is done. | Validation of processes and procedures is a common practice. |
| Validation is frequently used for processes and procedures. | Typically, calibration is done on measuring tools or instruments. |
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Validation is done in the ways listed below.
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Calibration is carried out as follows:
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| There are no reference standards available for comparison in validation. | Values are compared to reference standards during calibration. |
| The pharmaceutical industry's validation team performs validation. |
A third party normally does calibration. |
| No certificate is needed for validation; only supporting paperwork is. |
A calibration certificate is necessary for calibration. |
| There is no time limit on validation. |
Certificates for calibration have set expiration dates. |
| Failure to pass validation indicates that the product is unfit for usage. |
If calibration fails, the gadget isn't prepared to deliver the desired outcomes. |
| To establish the standard operating procedure, different samples are taken during validation at various intervals. |
A gadget is calibrated by being tested against several value ranges. |
| Modifications may be used to fix validation failure. |
Repairing could be used to address calibration failure. |
| After adjustments and rerunning the activity, the validation results are acceptable. |
After repair, calibration results are satisfactory. |
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Illustrations of calibration
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Illustrations of Validation
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