One submission covering formulation, ingredient documentation, allergens, packaging, label content and claims. Required documents change with the declared route of administration and product category. Incomplete packets cannot be submitted — the gaps are listed at the bottom of the page as you work.
Agreement & SKU Basics
SOP §2.4, §7.2Phase 1 does not open without an executed Quality/Technical Agreement covering formula ownership, release authority, label and claims responsibility, and change notification.
Recorded here for intake only; it lives in the onboarding record, not in general circulation.
Determines which CSQ Module 3B/3C sections and which label elements apply.
Stated by the brand, not inferred. Sets required documentation for every ingredient below.
An MMP is required per batch size.
A date already committed to retailers before intake is a scheduling risk worth naming now.
Formulation
SOP §7.2, §10.3The complete quantitative formulation. Every component with a weight or measure — a recipe is not a specification.
Non-Cannabinoid Ingredients
SOP §8.0Every NCI in the formulation, with its documentation. Required documents are set by the route of administration declared above. Attach the actual files — a checkbox is not a document.
Suppliers
SOP §8.5Every supplier of an ingredient or packaging component. A qualified ingredient from an unqualified supplier does not clear Phase 2.
Allergens
SOP §11.0 · Part 128 §128.5(b)(1)Two separate questions: what the label must declare, and whether the facility can make this without cross-contact. The second can constrain a SKU independently of the first.
Packaging Specification
Part 128 §§128.2, 128.3, 128.4Reviewed before procurement. A package problem found after a print run is a cost problem and a compliance problem at once.
A date chosen for shelf appeal is not a basis.
Label Compliance Worksheet
Part 128 §§128.5, 128.6Complete this against the actual artwork before submitting it. The required elements below change with the product category and route selected in section 1.
A processor identified on the label shall not be a processor which only labeled or branded the product. Where multiple processors appear, one that satisfies that condition must be clearly identified using the word "Manufacturer."
Tick any term appearing on the package or in marketing. Each carries conditions that must be met before it can be used.
Claims Register
SOP §13.3 · Part 129 §129.2(b)(9)Every claim appearing anywhere on the package or in accompanying material, listed with where it appears. Claims are captured here and routed to the CCO — they are not evaluated in this form, and substantiation is the brand's obligation.
Marketing & Accompanying Material
Part 129 §129.2Material this facility produces, prints, or transmits on the brand's behalf. Where the brand handles its own marketing entirely, say so here and confirm the responsibility allocation.
Notes & Prior Experience
SOP §22.2Context that helps the NPI Lead size the runway. Nothing here blocks submission.
Intake packet received
This SKU file is queued for Compliance completeness verification under SOP §7.3. Nothing has been sent to production, and no gate has been closed. The NPI Lead will follow up if anything further is needed.