Let us tell you a dirty little secret about the supplement industry..
Most supplement brands not only rely entirely on external manufacturers to create their products, but also to carry out any quality control.
Quality
That means they completely rely on the word of their manufacturer for quality.
Our worst nightmare would be to discover in 10 years time that we had been selling a product that wasn’t to the standards that we thought it was, so we’re not leaving it to chance.
And while most manufacturers have a great deal of integrity, there’s always one or two bad apples.
We built this brand for ourselves and our families first and we take our own products, so it goes without saying that quality is everything to us.
Why we have other supplement brands shaking in their booties...
Unlike the majority of supplement brands, we're taking on the same responsibility as the manufacturer to ensure quality. It goes well beyond simply doing 3rd party testing (which we of course still do).
That’s why we work to ensure we fully understand:
- The source of components, ingredients, and packaging materials;
- Manufacturing and packaging controls;
- Testing controls;
- Specifications;
- Any problems during manufacture;
Unsurprisingly, this is an expensive process. It’s also a complex one.
For example, most supplement brands are not familiar with the requirements of 21 CFR §111, 21 CFR §117 and 21 CFR §101 (specifically 21 CFR §101.36), nor do they take the steps in order to assure that their products are fully compliant with those requirements.
If we haven’t lost you yet, read on.
The 3 levels of auditing that we carry out (it gets our auditors hot under the collar):
- Engage our manufacturers quality team and request copies of their up-to-date cGMP certificates; further request that they provide us with the findings from their most recent independent site audit and their response thereto; verify their willingness to provide transparency with regard to their component CoA, minimally-redacted batch records and discuss their finished goods release process.
- Submit a self-audit compliance questionnaire for their Quality team to fill out and return. These sometimes contain as many as 350 questions. Request a copy of their Org chart, their SOP Table of Contents, and a number of other documents. Review it all, follow up with questions as may be required.
- Do the above, then schedule a site visit to audit their facility and practices. Submit a pre-audit checklist, and focus on any areas deemed to be weaknesses following a review of the self-audit questionnaire, paying close attention to other categories like sanitation, equipment and facilities maintenance, OOS investigation procedures, etc.
All of this is carried out by a highly experienced team of experts, led by our quality director who’s a trained ISO 9001/13001 internal auditor and has dozens of years of experience under his belt.
So when we say we’re quality freaks, we mean it.
Discover our collection of quality 3rd party tested health supplements below.