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Admin-Pharmaceutical Guideline

Periodic Review and Requalification

Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained in a qualified state throughout the life-cycle of the utility or equipment.

  • Utilities and equipment should be maintained in a qualified state throughout the life-cycle of the utility or equipment.

  • Utilities and equipment should be reviewed periodically, to confirm that they remain in a qualified state or to determine the need for requalification.

  • Where the need for requalification is identified, this should be performed.

  • Principles of risk management should be applied in the review and requalification and the possible impact of small changes over a period of time should further be considered (such as, through change control).

  • Principles of risk management may include factors such as calibration, verification, maintenance data and other information.

  • The qualification status and periodic requalification due dates should be documented, for example, in a qualification matrix, schedule or plan.

  • In case a utility or equipment in use is identified that has not been subjected to qualification, a qualification protocol should be prepared where elements of URS, design specifications, operation and performance are verified for acceptability. The outcome of this qualification should be recorded in a report.






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