Validation is the documentary evidence for determining the consistency of the analytical method and manufacturing process. During the process, data shall be collected for its evaluation and determines any process producing a consistent result over the time of period as per predetermine criteria.

Calibration is done to ensure the correct operation of the equipment or a process as per operating specifications. It shall be performed periodically to identify the drift of equipment and make them accurate. Calibration always does against the standard reference, as calibration of weighing balance done periodically against the certified value of weighing balance.

Qualification is the act of planning, carrying out, and recording the results of tests which is performed on equipment to confirm the capability of its working and to display that it will perform routinely as intended as and against predefined acceptance criteria mentioned in the supplier’s recommendation/ design qualification specification and guidelines. Qualification shall be performed or related to equipment, instruments, facility, and area before its use. The qualification has various stages like user requirement specification (URS), factory acceptance test (FAT), site acceptance test (SAT), Design qualification, installation qualification, operational qualification, and performance qualification.

#Validation, qualification and calibration are not just one-off activities. They must be carried out on an on-going basis if a facility’s development, operation and maintenance are going to continue to meet all regulatory requirements. Validation involves the collection and analysis of data in a systematic manner that proves that an analytical method or manufacturing process will give consistent results that meet all specifications when carried out in the prescribed manner. Qualification is the analogous term for equipment and machinery. Installation qualification (IQ) is performed for new equipment, and operation qualification (OQ) and performance qualification (PQ) monitor the day-to-day running of that equipment. Calibration, meanwhile, is vital in proving and maintaining the legitimacy of qualification and validation. It is designed to show that any instrument or device gives results that fall within specified limits, in contrast to results produced using a traceable standard over a suitable range of measurements. Calibration must be carried out using qualified instruments by an accredited laboratory.