GMP and testing support for dietary supplement makers
Retailers and buyers are asking harder questions about what's in the bottle, and a certificate of analysis is only as convincing as the specifications and lab behind it. Supplement makers operate under FDA's dietary supplement cGMP rule, 21 CFR Part 111, which requires you to establish specifications (§111.70) and determine whether they are met (§111.75). We help supplement and nutraceutical companies build that evidence trail so it holds up when a customer or an inspector asks.
Specifications first, then testing
Many brands send samples out without written specifications, then struggle to decide whether a result passes. We help you define identity, purity, strength and composition specifications, plus limits on contaminants that may adulterate the product, for components, in-process steps and finished batches, and decide what to test and how often.
Choosing and managing labs
We don't run tests in-house. We help you pick contract labs suited to each method, for example by checking whether their scope of accreditation covers the test you need. We also help you write clear test requests and sampling instructions, check that each method is scientifically valid and appropriate for its intended use, and review the results before they reach a COA. When a specification isn't met, we help you support your quality control team's material review and disposition decision, documenting the investigation instead of simply retesting.
Supplier and ingredient documentation
Supplier COAs alone often aren't enough. Part 111 requires at least one appropriate identity test or examination of each dietary ingredient before use. For other components, you can rely on a supplier COA only after you qualify the supplier by confirming its results, and you must periodically re-confirm them. We help you set this up and document it, organized so it's easy to retrieve during an audit.
Audit and inspection readiness
Gap assessments and mock audits against Part 111 and your customers' audit standards, followed by a practical fix list. If you have microbial limits on your products, we can also help you set up a right-sized environmental monitoring program and planning for cleaning validation.
Where engagements usually start
Common triggers are a new retailer's quality questionnaire, a product launch, a contract manufacturer change, or an inspection finding. We start by pulling one product's full paper trail: supplier documents, specifications, batch record, test results and COA. Following one product from start to finish quickly shows where the system holds together and where it breaks. From there we agree a fixed scope, so you know what you're paying for before work begins, and your team keeps every template and procedure we build.
Related services
Frequently asked questions
Is a third-party COA enough on its own?
Usually not. For dietary ingredients, Part 111 requires your own identity test or examination. For other components, a supplier COA can be used only after you qualify the supplier, and it has to list the methods, limits and actual results. We help you tie COAs to your specifications and a qualified lab.
Do you perform testing?
No. We help you choose, coordinate and interpret tests run by outside labs.
Download the pre-audit checklist or ask us to review your specs.