Equipment Re-qualification

How many batches need to be studied during equipment requalification

The number of batches required for equipment requalification depends on the type of equipment, the process being performed, the stage of the equipment lifecycle, and the risk assessment performed by the facility.

The International Conference on Harmonisation (ICH) guidelines provide recommendations for equipment qualification that require a minimum of three successful consecutive batches to be produced after installation, before routine commercial production can begin.

However, for equipment requalification, it is typically recommended to evaluate at least one batch to demonstrate that the equipment is still performing as intended and is capable of producing the required product quality. The number of batches required may be determined through risk assessment, and additional batches may be evaluated if there is a change in the equipment, process, or product being produced.

Ultimately, the number of batches required for equipment requalification should be determined by the facility’s quality management system and their established procedures for equipment qualification and risk management.

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