|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.|
|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).|
|In calibration performance of an instrument or device is comparing against a reference standard.
|No such reference standards are using in validation program.|
|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.|
|Shall be performed as per calibration SOP.||Shall be performed as per validation protocol.|