Gloved Fingertip Sampling
During inspections it has been observed that gloved
fingertip sampling is not always being performed. The
requirement in USP Chapter <797> is that
All compounding personnel shall successfully
complete an initial competency evaluation and
gloved fingertip/thumb sampling procedure
(zero [colony-forming units]) no less than three
times before initially being allowed to compound
[compounded sterile products (CSPs)] for human
use. After completing the initial gowning and
gloving competency evaluation, re-evaluation of
all compounding personnel for this competency
shall occur at least annually for personnel who
compound low and medium-risk level CSPs and
semi-annually for personnel who compound
high-risk level CSPs using one or more sample
collections during any media-fill test procedure
before they are allowed to continue compounding
CSPs for human use.
Please note, documentation of completion of gloved
fingertip sampling must be available for each individual
who engages in the preparation of compounded sterile
drug products.
quoted from here
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