Periodic review criteria for reviewing/updating SOPs

Periodic review/update of SOP (resign of SOP) is

  • Mandatory criteria and requirement to resign the SOP at predefined interval

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  • sign off review (pre-defined evaluation )checklist and trigger if&as appropriate.

    Votes: 0 0.0%
  • review sign off is not relevant/required to be defined, incidents-change controls address it

    Votes: 0 0.0%
  • others~!

    Votes: 0 0.0%

  • Total voters
    0

v9991

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#1
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?
 
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yodon

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#2
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.
 
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