Monday, September 16, 2013

What If You Needed SOPs to Run Your Household?

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:

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.