What is a Periodic Validation Review (PVR)?

A PVR is a review of a validated system on a predetermined regular basis to ensure ongoing control and compliance with site validation/regulatory requirements for the system. Historical performance of any Critical Process Parameters (CPPs) is evaluated over the review period to ensure deviations from expected operating conditions, if any, are properly addressed by the quality system. The scope of a PVR includes review of any physical or associated documentation changes to equipment, facilities, utilities, or process controls which have potential impact to the validated status of the system.

How are PVRs conducted?

Review of validation documentation over the defined review period includes evaluation of all validated aspects of the system, including but not limited to:

• Changes to installation or operational system status
• Maintenance and/or calibration history
• Governing operating procedures,
• System drawings
• Controls trending
• Deviation and Corrective Action / Preventive Action (CAPA) reporting.

How often should I perform a PVR?

The frequency of PVRs is determined based on level of GxP impact and the interval is often governed by site validation/regulatory requirements. PVR requirements and intervals are determined by the risk associated with, or criticality of, the item covered in the system validation. Higher Risk means More Frequent PVRs. The due date for a PVR is determined by date of the most recent PVR or last full validation / re-validation, and is tracked by the validation management system.

For more information on PVRs, please contact cGMP Consulting today at Info@cgmpconsulting.com!

Jeremy Wallace, Project Engineer                  Blake Wallace, Project Engineer