Requalification in pharmaceutical manufacturing is the systematic process of periodically verifying and documenting the ongoing suitability, reliability, and performance of facilities, utilities, equipment, processes, and systems. This ensures their sustained alignment with predefined requirements, specifications, and standards. The process encompasses activities such as periodic testing, calibration, validation, or inspection, alongside the review and updating of procedures, documentation, or training to accommodate changes or enhancements. Requalification is crucial for maintaining equipment and processes in a validated state, upholding current standards, and ensuring their intended performance and reliability are preserved throughout their operational lifecycle, thereby contributing significantly to product quality.
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