Calibration and validation of analytical instruments

INNOVATIVE analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical sector to get accurate data and to help ensure that products meet their specifications.

- S Unnikrishnan

Many of these analytical apparatus/instruments combine a metrological function with software control.

There are many methods to demonstrate that an instrument is qualified and under control, and these can be included - qualification, calibration, validation and maintenance.

Calibration is for verifying the outcomes of pharmaceutical process measuring instruments against standard reading values. If the output/outcome follows the standard readings, the calibration is fully successful and the measuring instruments is safe for all applications of analytical processing.

Analytical instruments are used for specific analysis of pharmaceuticals. A periodical performance verification is required to ensure the analytical equipment used in the analytical purpose should be properly calibrated and validated to confirm that it is suitable for its intended purpose. Calibration of an equipment can be done in two methods such as internal calibration and external calibration.

Calibration process

Calibration is the process which ensures that instrument readings are accurate with reference to established standards. Calibration is performed by using primary standard. It is done to check the zero-error deflection by using standard reference.

The need to calibrate and qualify analytical instruments and systems is well recognized in analytical laboratories. However, calibrating and qualifying analytical instruments and systems are seen as discrete tasks. There is an increasing regulatory expectation that a risk-based life cycle approach is necessary to ensure fitness for purpose as part of analytical procedures.