If you are a small manufacturer of dietary supplements, hemp oil derivatives, or functional foods, here’s how I can help you.
I create a document management system for cGMP compliance that is low cost and high quality.
I will create standard operating procedures (SOP’s), Master Manufacturing Records, and a complete management system to comply with CFR 21 parts 111, 110, & 117 for your solid dose, liquid, and powder finished goods.While the FDA continues to not totally enforce the DSHEA (Dietary Supplement Health and Education Act) of 1994, the smaller manufacturer often feels it is a low priority.
I get that, but here’s the thing. If you want to obtain better customers that will provide you with larger orders and more stable receivables, having a cGMP program in place can get you there. These more established customers require your facility to be cGMP.
Also, at the same time, you are reducing your regulatory risk because, at any time, an FDA or state agency can show up or make initial contact with you without warning. This is where the headaches and heartaches can begin. I have seen enough surprise FDA 483’s issued in my 30 years in this space.
And we all know the famous saying about human nature; “It is not a problem until it’s a problem.
There are additional benefits to a well-constructed cGMP system. It significantly reduces errors throughout the PPC (Production Process Control) chain.
A large part of my mission is to help small and medium-sized enterprises develop and create cGMP document management systems that improve their odds of increasing revenue and profitability and get to the next level.