Many of us are having confusion between the terms validation, calibration, and qualification used in pharmaceutical industries. So let’s do it easy to understand with examples.
Qualification: 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.
Qualification shall be performed for all new/ existing equipment, facility, system, and instrument by the user with the help of the manufacturer/ supplier of the equipment, instrument, system, and facility, with a well-trained qualification team and engineering person. For the manufacturing process, we need personnel, equipment’s instrument facilities, area, systems, or software that need to be qualified first before proceeding to the validation process.
All the equipment’s system shall be performed for qualification after every one year to 7 years from the date of the last qualification. One batch shall be taken for the performance qualification of manufacturing equipment.
Validation: 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.
Process validation is categorized into three-stage: stage 1 – process design, stage 2- process qualification, and stage 3- continue process verification. Validation shall be performed to identify the risk assessment which is involved in the process and in the 3method for deep study and to understand the system the process validation is required.
Validation shall be performed for the water system, cleaning of equipment, manufacturing process, HVAC system, analytical method, computer system, and water system. for the manufacturing process, validation of three consecutive batches shall be taken.
Periodic re-validation shall be performed every five years or as per in-house validation protocol( with proper justification) with one batch in line with the process qualification requirement.
Calibration: 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 is done periodically against the certified value of weighing balance.
Why Validation Calibration and Qualification is important?
Validation Calibration and Qualification are part of the quality system. Drift in one of them may cause loss of product quality. So it shall maintain it over long periods of time, which help in the improvement of product quality, system, safety, and regulatory requirement.