Periodic review criteria for reviewing/updating SOPs

[v9991]

all the SOPs are reviewed and revised/updated at some frequency (typically 2 years, but the review criteria is not always predefined or even outlined beyond a very high level, viz., trends of incidents etc )

the question is, it really mandatory to revise/update (resign) the document at a predefined intervals?
OR
is it adequate to sign-off an evaluation of predefined-criteria of evaluation and carry out re-siogn (revision/updation) of SOP, only if above assessment recommends for it?

 

[yodon]

I think your initial premise is incorrect: "SOPs are reviewed and revised/updated at some frequency" (emphasis added).

21 CFR 820 definitely calls out for a review but no updates are mandated unless warranted. The Management Review is typically where I've seen the "periodic review" occurs (which lines up with 820.20(c)). If not done in / as part of the Management Review, you would have to define how you document the dates and results of quality system reviews.