CALIBRATION | VALIDATION |
Calibration is a demonstration that, a particular Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
| Validation is a documented program that provides high degree of assurance that a specific process, equipment, method or system consistently produces a result meeting pre-determined acceptance criteria.
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In calibration performance of an instrument or device is comparing against a reference standard.
| No such reference standards are using in validation program. |
Calibration ensures that instrument or measuring devices producing accurate results. | Validation provides documented evidence that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).
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Shall be performed periodically, to identify the ‘drift’ of the measuring device or equipment and make them accurate.
| No such requirements. Shall be performed when changes or modifications happen to the existing system or once revalidation period is reached.
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Shall be performed as per calibration SOP. | Shall be performed as per validation protocol. |