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 rananikesh@ymail.com
I have task to prepare periodic review report.