Start with the finished dose
Translate the formula into an ingredient brief. Record the target EPA and DHA per serving, number and size of dosage units, liquid or powder format, intended market and any label constraints. Then calculate the ingredient profile needed to meet that target, allowing for other ingredients and process losses where relevant.
For every assay value, specify the units, basis and acceptance criteria. “50/20” may be understood as EPA/DHA percentages by some teams, but a controlled specification should say exactly how values are expressed and tested.
Keep ratio, form and concentration distinct
EPA/DHA ratio, total omega-3 concentration and molecular form answer different questions. State each separately: for example, a target profile, whether EE/TG/rTG is required or open to evaluation, and any minimum total omega-3 level. Do not assume a named ratio alone defines the ingredient.
If alternative forms are acceptable, ask suppliers to quote them as separate options with separate specifications and documents. That makes cost and formulation trade-offs visible.
Set quality and document requirements
Define oxidation criteria for PV, p-anisidine value and TOTOX with the applicable test methods and product type. Add contaminant, sensory, microbiological or residual-solvent criteria only as relevant to the product and destination market. State which results must appear on each lot’s COA and which may be supplied through periodic verification.
List the supporting files required for approval: specification, batch COA, test reports, safety data, traceability, certificate scope, packaging and storage information. Validate regulatory requirements with the responsible quality or regulatory team.
Include packaging and supply assumptions
Specify pack size, headspace or nitrogen requirements, storage conditions, destination, shipment method, forecast volume, sample quantity and target use date. Ask suppliers to identify assumptions about minimum order, lead time, batch reservation and substitutions in the quote.
Custom fish oil specification checklist
- EPA, DHA and total omega-3: units, assay basis and limits.
- Molecular form and acceptable alternatives.
- Application, serving target and destination market.
- Oxidation and contaminant criteria with test methods.
- Required batch and supporting documents.
- Packaging, storage, volume, sample and shipment assumptions.
Control revisions through approval
Assign a revision and effective date to the specification. Link each quote, sample, COA and purchase order to that revision. If a supplier proposes a change to source, process, form or method, review it before accepting the next lot. This creates a clear record from development through repeat orders.