Difference between Validation VS Calibration

By: Pharma Tips | Views: 55820 | Date: 21-Jan-2013

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 is a demonstration that, a particularInstrument 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.

Difference between Validation VS Calibration



Process Validation

               
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.

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).

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.

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Comments
rohit  |  17-Feb-2015 20:22:56 IST
good ans. for ipqa performance in pharma industry......
ashutosh mishra  |  24-Sep-2015 12:53:16 IST
good to understand, very simple, helpful to all pharma friends
Jagdish Harish Patil  |  28-Apr-2016 19:11:01 IST
QA formulation
Rohit Sinhal  |  09-Feb-2017 12:15:24 IST
Good Answer
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