Softgel Manufacturing FAQ: Private Label, Custom Production and Retail

Stock softgels use an existing supplier formula as finished inventory or bulk awaiting packing. Custom softgels require a defined fill, shell, shape or pack and development approvals. Ask which route the quote covers, what can change and which minimum applies.

Multiply bottles by softgels per bottle to calculate total pieces. Ask for the minimum and committed saleable yield in both units. Two figures match only at the stated count, so recalculate them whenever you change softgels per bottle.

Choose against formula compatibility, label requirements, target markets, release needs and stability evidence. Request the complete polymer and plasticizer composition for gelatin or plant options. A broad vegetarian or gelatin label does not answer those technical questions.

Bovine, porcine and fish gelatin create different traceability, allergen, religious and market questions. Request species, origin and supporting documents for the exact shell. Gelatin origin alone does not establish finished-product Halal, Kosher or other certification status.

No. Review the fill, flavors, colors, processing aids and every other input as well as the shell. Fish oil remains non-vegan inside a plant shell. Request documents for the complete product rather than relying on a shell marketing term.

Request the current certificate, issuing organization, covered site, lines, activities and product scope. Assess all ingredients and processing aids, not just gelatin species. Confirm that your SKU and claims sit within scope before using a certification mark.

List every fill and shell component, then ask about migration, moisture, softening, brittleness, cross-linking, suspension behavior and sealing. Test the proposed commercial combination in its pack. Do not transfer a conclusion from another formula or shell without supporting evidence.

No. The oil fill mass and the declared active amounts differ. Request EPA and DHA in milligrams per softgel, the oil concentrate specification and assay method. Use those active amounts to set the serving and compare formulas and quotes.

Discuss incoming oil and finished-product testing for peroxide value, p-anisidine and TOTOX where suitable for the matrix. Ask whether flavors or pigments interfere. Set product-specific criteria with qualified support and use finished-pack stability evidence for shelf life.

Record the defect, lot, pack and storage or transport conditions, preserve samples and follow your hold procedure. Ask the manufacturer to investigate seams, shell state, drying, handling and pack pressure. Define acceptance, notification and disposition rules in advance.

Fill mass and density give an estimated volume, while the supplier's die chart and process needs determine feasible size. Set the active amount per softgel, then decide how many softgels make a serving. Larger servings change bottle count and cost.

No. Request the method, acid-stage conditions, delay and release criteria, plus results for the finished formula. Check performance in the commercial pack and during stability when relevant. Keep label and marketing claims within product-specific evidence and applicable rules.

Assess oxygen, moisture, light and transport risks for the formula, then test the proposed commercial pack. Match stability samples to the bottle or blister, closure and seals used for sale. Require approval before substituting components or adding desiccants.

It reports lot-specific test results against approved specifications, such as identity, active assay, microbiology, contaminants, fill weight or physical checks based on risk. Confirm methods, acceptance criteria and the tested lot. Release results do not prove shelf life.

Choose the consumer pack and shipper for the actual route, run appropriate conditioning or shipment trials and inspect leakage, sticking, seals and lot codes. Track defects by lot and route. Investigate patterns with the manufacturer and fulfillment partner.

Requirements depend on current Seller Central and account instructions. Prepare labels, ingredient information, lot-specific certificates and applicable product-specific certifications, then follow the account request. GS1 identifiers and accredited documents support records but never guarantee listing acceptance.

Set the minimum with the distributor in the supply agreement and purchase order. Check that production, quality release, transit and receiving fit inside the stability-supported expiry. Define the measurement point and the process for lots that miss the window.

Confirm formula and artwork versions, ingredient and pack suppliers, shell, die, test methods, expiry basis and every change since the prior lot. Recalculate the minimum in pieces and packs. Obtain lot-specific release documents for each new production run.