Periodic review

Does FDA requires periodic review be conducted?

Yes. FDA does require periodic review of API (see ICH 7A) and other oversight items. If you have access to 483s, a search for periodic review will show that companies have been written up for failure of a periodic review.

I have been a 2 companies recently (as a consultant), and one was written up for a failure to perform a periodic review of the process (process validation) and the other was written up for failure to do periodic review of equipment. I believe the review time was set at 3 years for both companies.

Basically the periodic review is to supplement the change control process. Small incremental changes might not result in a process change with each step, but many small changes added up might warrant a re-validation in FDA’s eyes. There are other reasons for a periodic review such as unknown changes creeping into the process, or a trend that isn’t caused by a change, rather gradual natural creep (parts wearing out, etc.).

Also, just found the Code of Federal Regulations about this

FDA 21 CFR 211.68(b)
 “Input to and output from the
computer or related system of
formulas or other records or data
shall be checked for accuracy. The
degree and frequency of input/output
verification shall be based on the
complexity and reliability of the
computer or related system.”

This is specifically about periodic review

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Is there having format example of periodic review of any equipment. So please mail me
I have task to prepare periodic review report.