Turning a formula into a product

Plenty of people can put together a blend that tastes good. A product is that blend with a specification, evidence, and a label whose numbers are true.

A formula is not a product

A formula is percentages. A product is the formula plus a process, a package, qualified suppliers, identity and potency evidence, a Supplement Facts panel derived from the formula, and the records 21 CFR 111 expects.

The gap is mostly documentation, and it is the gap between a hobby and a business.

What has to be pinned down

Components as percentages by weight with the batch size separate. The process: pre-blend steps, blend time, blender and fill level. The specification: label claim, manufacturing target including overage, acceptance ranges, particle size expectations.

The package, because the seal is part of the stability case. The suppliers, because a substitution is a change. And the scoop, calibrated against this blend.

The panel comes from the formula

Derive amounts per serving arithmetically from the percentage composition and the serving size, in a document that recalculates. Never type them into artwork independently.

And check the arithmetic between net weight, serving size and servings per container, because those three must agree and the check is the one most often skipped.

When it is a product

When somebody competent but unfamiliar could make it from the written process and produce a batch that assays the same, and when you could answer, for any tub in the market, what is in it, which supplier lots it came from, and what the blend uniformity was.

Until then you have a formula you happen to sell, which works until the first question you cannot answer.

References