Last week I traveled
to Phoenix to videotape a presentation for Natural Products INSIDER’s upcoming Digital
Summit. The 45-minute presentation,
entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes
into much more detail than our February
blog post on the same subject (which you can read here: http://bit.ly/YGTQWd).
Rosanne
Sylvia-Heeter, Director of cGMP Compliance at Polaris, is always chanting the
FDA compliance mantra, “If it’s not documented, it didn’t happen.” As I worked on the blog post with her last
winter, I was struck by the amount of documentation actually needed to comply
with 21 CFR Part 111 distribution regulations.
As we worked on the Digital Summit presentation this summer, I was
struck by something else. In the course
of simply maintaining a residence, members of my household actually perform a
lot those Part 111 activities. And so do
yours.
The
big difference is that we don’t have to write it all down.
