12.23.2015

FDA cGMP compliance project update

This week saw an excellent development in the quest to provide open-source resources to the herbal community in our efforts to achieve compliance with FDA cGMP regulations: AHPA (the American Herbal Products Association) has posted hundreds of document templates, including manufacturing record templates, testing method templates and specifications, policy templates for almost anything you could imagine (and more) that might be involved in making an herbal dietary supplement. This is a great resource (thank you Ellen Kahmi, http://www.naturalnurse.com for bringing this to my attention the day it was released). Find it here:

http://ahpa.org/Resources/cGMPSOPTemplates.aspx

As you can see, the list of available documents is quite extensive. It is available for members of AHPA (base-level membership for a small-scale manufacturer is $1,000 per year. AHPA is a fantastic organization. $1,000 is a lot of money).

Another development is that I will no longer be posting updates and documents at this site, but rather at a new dedicated site where you can find all previous information and also future updates. Find it here:

https://sites.google.com/site/gmpopensource/home

Hopefully this will be a more practical way for us to communicate about this. Over the next few weeks, I will be reaching out to folks who have expressed interest in helping, to make them contributors to the site and allow them to edit and add material as they see fit. There are a few items I might suggest putting on our agenda and to-do list for this project:
- live online forum discussion to help us meet, define the work, and agree on goals
- working through explaining the pieces of cGMP compliance (more documents and voice-overs of why they are structured the way they are, and how to customize them for your own business)
- the problem of testing, and its cost: even a testing program that takes random annual samples (which requires some baseline level of confidence in raw materials and in-house manufacturing, and data to support it) still can run hundreds or thousands of dollars, depending on how many products you make
- the lingering uncertainty around defining identity and strength specifications, and testing for those specs, for a multi-botanical herbal dietary supplement.

I'm taking next week off. Stay tuned at https://sites.google.com/site/gmpopensource/home for further updates in the new year.

1 comment:

D said...

Thank you in advance for this amazing resource!