Supplement manufacturing 10 step framework
How HBM moves a project from NDA to final release at the Tampa Bay facility.
HBM's supplement manufacturing 10 step framework is the fixed process every gummy and liquid project follows at HBM's Tampa Bay, FL facility. The ten steps run from NDA signing through discovery call, formula review, formal preliminary estimate, bench samples, packaging review, quote and PO, pilot batch, commercial production, and final release. Preliminary estimates come back in 24 hours. Bench samples take 2-4 weeks. Pilot batches take 2-4 weeks. Commercial production runs 4-8 weeks. The framework holds across both pillars under one quality system and HBM's 8 certifications, including FDA Registration, NSF, and USDA Organic.
Most contract manufacturers describe their process in three or four steps. That hides where projects actually slow down: artwork, regulatory sign-off, vendor lead times, and the handoff between formulation and packaging. HBM’s framework names ten steps because there are ten. Each one has an owner inside HBM and a deliverable the buyer can verify.
1. NDA signing
The mutual NDA covers both directions. HBM signs first or countersigns the buyer’s template. Either path works. The NDA stays in force through bench samples, pilot, and commercial production. See [/r-and-d/nda/](/r-and-d/nda/) for the standard terms.
2. Discovery call
A 30-minute call with R&D. The buyer brings the product concept, the target market, the regulatory geography (US, Canada, EU), and any constraints on ingredients, claims, or label. HBM brings the questions that surface scope risk early. The output is a one-page brief that drives the next two steps.
3. Formula review
R&D reviews the buyer’s existing formula or starts from the brief. The review covers active load, base system compatibility, heat sensitivity, gelling interference, and label-claim math. For gummies, the active load ceiling is 33% by weight with 10-17% as the typical working range. For liquids, the review covers solubility and the carrier system (water-based, oil-based, emulsion, liposomal, or suspension).
4. Formal preliminary estimate
HBM returns a formal preliminary estimate within 24 hours of the formula review. It covers unit cost at the requested run size, MOQ, lead time bands, and any flags from the formula review. MOQs follow the published floors. Gummies are 300,000 units, or 600,000 at smaller mold sizes. Liquids are 3,000 units or 150L. The estimate is the document that gets the project funded internally on the buyer side.
5. Bench samples
Bench samples take 2-4 weeks. R&D produces small-scale samples in the 3,000 sq ft R&D lab attached to the St. Petersburg gummy facility. Buyers receive labeled samples for sensory review, stability hold, and any third-party testing they want to run. Reformulation cycles happen here. Most projects need one to three rounds.
6. Packaging review
Packaging review runs in parallel with bench samples once the formula is locked. The review covers bottle, closure, induction seal, label, carton, and case. HBM provides a packaging spec sheet for each component. The buyer’s chosen vendor ships components to HBM under the agreed lead time. See [/gummies/packaging/](/gummies/packaging/) and [/liquids/packaging/](/liquids/packaging/) for the standard component lists.
7. Formal quote and purchase order
With the formula and packaging locked, HBM issues the formal quote. It supersedes the preliminary estimate. The buyer issues a PO against it. Payment terms, deposit schedule, and component-receipt milestones are written into the PO. The PO is the trigger for pilot batch scheduling.
8. Pilot batch
Pilot batches take 2-4 weeks. The pilot proves the formula and the process at a fraction of commercial scale. For gummies, that means a run on one depositing station. For liquids, that means a 150-500L batch in one mixing vessel. The pilot batch generates the master batch record that commercial production will reference.
9. Commercial production
Commercial production runs 4-8 weeks from PO confirmation, assuming components are on site. Gummy lines can deliver 3,000,000 units per day at peak. Liquid lines can deliver 25,000 liters per day. Every commercial batch references the master batch record from the pilot. QA holds samples, retains records, and issues the CoA. See [/r-and-d/commercial-production/](/r-and-d/commercial-production/) for the production-floor detail.
10. Final release and shipment
Final release requires the batch record, CoA, and any third-party tests called out in the PO. QA signs off. Finished goods ship to the buyer’s 3PL or warehouse on the agreed Incoterm. HBM retains samples and batch records for the regulatory retention period required by FDA, Health Canada, or the buyer’s chosen market.
Where projects gain or lose time
Inside HBM’s process, the variance is small. The 24-hour preliminary estimate is firm. Bench and pilot windows are 2-4 weeks each. Commercial is 4-8 weeks. The wider variance comes from outside the plant. Artwork revisions sit outside HBM’s process. Regulatory sign-off sits outside it. Component lead times depend on the buyer’s chosen vendor. A clean project with locked artwork and stock components moves fast. A heat-sensitive active in a sugar-free system at 25% load lands at the long end.
What stays constant across the framework
The framework holds for gummies and liquids alike. Same R&D team. Same QA system. Same 8 certifications. For [gummy manufacturing](/gummies/), that means four continuous depositing stations at 300KG/hour each (two run at a time) for a combined 600KG/hour. For [liquid manufacturing](/liquids/), that means 2,500L of total mixing capacity across three 500L vessels and one 1,000L vessel. Bench sample to commercial run happens under one roof. No partner handoff.
Frequently asked questions
How long does the full 10 step framework take end to end?
At HBM, a typical project runs 8-16 weeks from NDA signing to final shipment. Bench samples take 2-4 weeks. Pilot batches take 2-4 weeks. Commercial production runs 4-8 weeks. The preliminary estimate comes back in 24 hours. Wider timelines usually trace to artwork, regulatory review, or component lead times. Those sit outside HBM's process.
Can the framework be compressed for a rapid launch?
Yes. HBM offers a rapid launch path for projects using existing base systems and stock components. The 10 step framework still applies. Bench rounds get reduced. Pilot and commercial sometimes run back to back. See [/r-and-d/rapid-launch/](/r-and-d/rapid-launch/) for the qualifying criteria. Custom molds, novel actives, or sugar-free formulations do not qualify.
What does HBM need from the buyer to start step 1?
HBM needs a signed NDA and a one-paragraph product brief. The brief covers the product type, the target market, and the rough ingredient list. That is enough to schedule the discovery call. Formal specs, formulas, and label drafts come into the process at steps 3 and 6. HBM provides templates for the brief and the formula intake form.
Does the framework apply to reformulation projects too?
Yes. Reformulation projects enter at step 3, formula review. The NDA and discovery call still happen. HBM evaluates the existing formula against the target outcome. That target might be cost reduction, label cleanup, or a switch from gelatin to pectin. See [/r-and-d/reformulation/](/r-and-d/reformulation/) for typical scopes. Timelines mirror new-product projects.
What documentation does HBM produce at each step?
HBM generates a one-page brief at step 2 and a formula review memo at step 3. Step 4 produces the preliminary estimate. Step 5 produces sample CoAs. Step 7 produces the formal quote. Step 8 produces the master batch record. Step 9 produces commercial batch records and the final CoA. Step 10 produces the release certificate. All records are retained per cGMP.