GLP Requirements and Quality Control Studies

Good morning everyone,

Today I'd like to ask about requirements on Good Laboratory Practices, and how they apply to stability studies of dietary supplement formulations.

The only language I've been able to find that clearly states that these basic stability tests don't require GLP SOPs/Methods/Documentation is #25 of this link:

https://www.fda.gov/...report-aug-1979

also copied here for convenience:

"Many toxicological studies are conducted on products or formulations, which are comprised entirely of materials which are known to be safe. Such studies are intended to be a quality control measure to determine lack of product integrity or to detect adulteration. Do the GLPs apply to such studies?

No. The Agency considers such studies to be quality control studies, which are not subject to the GLPs."

While I've found many more articles, guidance, etc. that while these stability tests are non-clinical and not going to be submitted to the FDA, that they should be following GLP as described in 21 CFR 58 and be documented as such.

To add a little more information: my company has a stability chamber for accelerated stability testing of our dietary supplement products/formulations to observe changes in composition or taste, and we submit samples to a third party lab to verify that no degradation of active/label claim ingredients has occurred. Beyond our own research and development for product formulation, this is the only type of 'study' we personally undertake in-house.

Does anyone have anything concrete they could share with regards to whether our practices fall under GLP, GMP, or any other such category under which I may not be documenting practices correctly?

Thank you to anyone who chooses to respond,

Yes, It's Still My First Day