I am performing periodic review of validated equipment and computer systems and the plant is in the process of re-evaluating the Periodic Review procedure.
I have been asked to perform a benchmarking on the frequency of performing periodic reviews in the industry to harmonize our procedure to the current tendencies.
I will appreciate any input on the frequency of the Periodic Review as performed in members’ workplace or from any other source such as recent seminars, conferences, FDA guidance, or comments.
GAMP 5 states that any Periodic Review activity schedule should be defined based on system impact, complexity and novelty. Another ISPE Good Practice Guide (Validation of Laboratory Computerized Systems) states that the review period typically range from one to three years. I have seen some cases where the periodic review activity frequency ranges from 1 to 5 years. Ideally you should perform a scientifically sound risk assessment that allows you to categorize your systems based on risk/criticality and define a time schedule based on that (high risk -> more frequent reviews).
Hi! First of all periodic review is required for computer based system/application, as these systems are likely to initiate change due to hardware/ software patch upgrades, database error. Guideline woould not tell you how frequently u should perform this activity.
You have to list down GxP system installed in to your organisation & based on it’s criticality of use & complexity, you have to define frequency of periodic review.
Typically, we are doing it once in a year.
I hope this could provide you some help.