cGMP under 21 CFR 111
Dietary supplement manufacturers must follow FDA current good manufacturing practice. Ask for their most recent FDA inspection outcome and any third-party GMP audit, such as NSF GMP registration.
Identity testing on every ingredient
The rule requires at least one identity test on each incoming dietary ingredient. Ask what they test in house, what they send out, and whether you get the results with each batch.
A certificate of analysis per lot
Each finished lot should ship with a COA that covers potency, microbials and heavy metals against your label claims. Agree on the specs in writing before the first run.
Batch records you can see
Ask to see a sample master manufacturing record and executed batch record. You will need them for retailer audits, Amazon compliance requests and any complaint investigation.
Stability and expiry dating
Find out how they support the expiry date on your label: real-time or accelerated stability, and who pays for it. The date drives how long your stock can sit.
Clear minimums and lead times
Minimums are often per SKU and per format, and gummies and softgels usually run higher than capsules. Get raw material lead times in writing, since they set your reorder point.