Turning a batch into a product
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A written specification
What the finished product must be: the ingredients, their amounts, the carrier, the strength. cGMP asks you to set specifications and then show you met them, which means the first step is deciding what the product is in writing rather than in practice.
Batch records that show you met it
What went in, how much, which lot, who did it, what the yield was. Not a notebook of intentions but a contemporaneous record, because the whole point is demonstrating that this batch was made to the specification.
A panel that matches the bottle
The Supplement Facts panel states a serving size and what is in a serving. That is a claim about the contents, so the formulation and the panel have to be settled together and a reformulation is a new panel.
Language you can defend
Every claim you intend to make, written down before the artwork, checked against the line, and with the substantiation you hold noted next to it. This is the document people skip, and it is the one that gets quoted back at them.
Then the notification
If you carry a structure/function statement, FDA has to be notified within 30 days of first marketing. That is a deadline that starts the day you sell, so it belongs in the launch plan rather than in a pile of things to do later.
What stops being optional
- Identity verification for each incoming ingredient lot.
- A batch code on every bottle, tied to those lots.
- The batch record, written during.
- A retained sample from every batch.
Settle the formulation before the artwork
The panel is a claim about contents, so every reformulation is a new panel and possibly a new notification. Launching on a recipe you are still adjusting means paying for the label twice and filing twice.