Supplement Manufacturing Glossary

Supplement Manufacturing Glossary

Sixty terms used in supplement sourcing, defined in one or two sentences so you can read a quote sheet without guessing.

How to use this glossary

This is Part 1 of the EUPHM Supplement Manufacturing Glossary, covering dosage forms, capsule and tablet technology, and quality and testing. Definitions are written for sourcing managers and brand owners who need to interpret quote sheets, specifications, and supplier documentation without assuming industry background. Each entry includes a short note on why the term matters in practice. Part 2 will cover regulatory and labelling, commercial terms, and logistics.

Dosage forms

Capsule
A solid dosage form in which the active ingredients are enclosed in a shell, typically made of gelatin or vegetarian materials such as HPMC. Capsules are commonly used for powders, granules, or liquids.
Capsules offer flexibility in formulation and are a common choice for pilot runs and small batches.
Chewable
A tablet designed to be chewed and swallowed, often flavored and sweetened to mask the taste of active ingredients. Chewables are common for multivitamins and mineral supplements.
Chewables can improve compliance for consumers who dislike swallowing pills.
Drop
A liquid dosage form administered in small volumes, typically by dropper. Drops are often used for pediatric or geriatric supplements and for concentrated actives.
Drops allow precise dosing and are suitable for products requiring high potency in small volumes.
Effervescent
A tablet or powder that dissolves in water with effervescence, typically containing an acid and a carbonate to produce carbon dioxide. Effervescent forms are used for rapid dissolution and taste masking.
Effervescent products require careful control of humidity during manufacturing to prevent premature activation.
Gummy
A chewable dosage form made with a gelatin or pectin base, often used for vitamins and supplements. Gummies require careful formulation to ensure stability and uniformity.
Gummies are popular for consumer compliance but have specific manufacturing and stability challenges.
Liquid
A dosage form in which active ingredients are dissolved or suspended in a liquid vehicle. Liquids include solutions, suspensions, and emulsions, and may be packaged in bottles or single-dose containers.
Liquids offer flexible dosing and are suitable for consumers who prefer not to take solid dosage forms.
Oral film
A thin, flexible strip that dissolves in the mouth to deliver active ingredients. Oral films are a convenient alternative to tablets and capsules, often used for rapid absorption.
Oral films require specialized manufacturing equipment and are best suited for products where convenience is a key selling point.
Oral spray
A liquid dosage form delivered as a fine mist into the mouth, typically via a pump or aerosol device. Oral sprays are used for quick delivery of actives and for products requiring precise dosing.
Oral sprays can improve absorption and are convenient for on-the-go use.
Powder
A dry, particulate dosage form that may be mixed with water or food before consumption. Powders are often used for protein supplements, fiber, and bulk actives.
Powders offer high active loading and are cost-effective for large doses.
Softgel
A one-piece capsule with a soft gelatin shell, typically used for liquids, oils, and suspensions. Softgels are sealed and offer good protection against oxidation.
Softgels are ideal for oil-based actives and provide excellent stability and bioavailability.

Capsule and tablet technology

Binder
A substance added to a tablet formulation to hold the ingredients together and improve granulation. Common binders include starch, gelatin, and cellulose derivatives.
Binders affect tablet hardness, disintegration, and stability, and must be selected carefully.
Coating
A layer applied to the surface of a tablet or capsule to protect the active ingredient, mask taste, or control release. Coatings can be sugar-based, film-based, or enteric.
Coatings can improve product stability and consumer acceptability.
Compression
The process of forming a tablet by pressing powder or granules into a die under high pressure. Compression is a critical step in tablet manufacturing, affecting hardness, porosity, and dissolution.
Compression parameters must be optimized to ensure consistent tablet quality.
Disintegrant
A substance added to a tablet formulation to promote the breakup of the tablet into smaller particles in the gastrointestinal tract, aiding dissolution and absorption.
Disintegrants are essential for ensuring the active ingredient is released and absorbed.
Enteric coating
A coating applied to a tablet or capsule that resists dissolution in the stomach and dissolves in the intestine. Enteric coatings are used to protect acid-sensitive actives or to target release to the intestines.
Enteric coatings are critical for products containing probiotics or enzymes that would be degraded by stomach acid.
Excipient
An inactive substance used as a carrier or to aid in the manufacturing, stability, or delivery of the active ingredient. Excipients include fillers, binders, disintegrants, lubricants, and coatings.
Excipients can affect product performance and must be chosen for compatibility with the active and the dosage form.
Granulation
The process of forming granules from fine powders, typically to improve flow, compressibility, and uniformity. Granulation can be wet or dry and is a common step in tablet manufacturing.
Granulation helps ensure consistent tablet weight and content uniformity.
Hard gelatin capsule
A two-piece capsule consisting of a cap and a body, typically made of gelatin. Hard capsules are filled with powders, granules, or pellets and are commonly used for solid dosage forms.
Hard capsules are versatile and can accommodate various fill materials.
Lubricant
A substance added to a tablet or capsule formulation to prevent sticking to manufacturing equipment. Common lubricants include magnesium stearate and stearic acid.
Lubricants can affect tablet hardness and dissolution and must be used at optimal levels.
Sustained release
A dosage form designed to release the active ingredient slowly over an extended period. Sustained-release formulations can improve compliance and reduce dosing frequency.
Sustained-release products require specialized formulation and manufacturing expertise.

Quality and testing

Accelerated stability
A testing method where products are stored under elevated temperature and humidity to predict shelf life. Accelerated stability studies are used to estimate expiration dating and formulation robustness.
Accelerated stability data support label claims and help identify formulation issues early.
Assay
A quantitative test to determine the amount of active ingredient present in a sample. Assays are typically performed using HPLC or other analytical methods.
Assay results confirm that the product meets label claims and specifications.
Certificate of Analysis (CoA)
A document provided by the manufacturer that reports the results of quality tests performed on a specific batch. A CoA typically includes assay, microbial, and physical test results.
A CoA is essential for verifying product quality and is often required for regulatory compliance.
Disintegration test
A test that measures the time required for a tablet or capsule to break down into particles under specified conditions. Disintegration is a critical quality attribute for solid dosage forms.
Disintegration test results indicate whether the product will release the active ingredient properly.
Dissolution
The process by which the active ingredient dissolves from the dosage form into a test medium. Dissolution testing is used to assess bioavailability and batch consistency.
Dissolution is a key performance indicator, especially for solid dosage forms.
Heavy metals
Toxic metallic elements such as lead, mercury, cadmium, and arsenic that may be present as contaminants in raw materials or finished products. Heavy metal testing is a standard quality control measure.
Heavy metal testing ensures product safety and regulatory compliance.
Microbial testing
A set of tests to detect and quantify microorganisms such as bacteria, yeast, and mold in a product. Microbial testing is essential for ensuring product safety and stability.
Microbial contamination can cause product spoilage and pose health risks.
Quality control (QC)
The set of procedures and tests used to ensure that raw materials, intermediates, and finished products meet specified quality standards. QC is a critical component of GMP.
A robust QC program is essential for consistent product quality and regulatory compliance.
Shelf life
The period during which a product is expected to remain within its approved specifications when stored under recommended conditions. Shelf life is typically determined through stability studies.
Shelf life is a key labeling requirement and affects product distribution and inventory.
Uniformity of dosage units
A test that ensures each dosage unit (tablet or capsule) contains a consistent amount of active ingredient. Uniformity is critical for product safety and efficacy.
Poor uniformity can lead to under- or over-dosing and regulatory issues.

Regulatory and labelling

Certificate of Free Sale
A document issued by a national authority confirming that a product is legally sold in the issuing country. Importers may request it to clear customs or register the product in the destination market.
Without it, some markets will hold your shipment at the border.
cGMP
Current Good Manufacturing Practice: the regulatory standard for consistent production and quality control. In the US, 21 CFR Part 111 applies to dietary supplements; the EU and other markets have equivalent rules.
A supplier's cGMP status is the first thing an auditor or importer checks.
Dietary Supplement Health and Education Act (DSHEA)
The 1994 US law that created the dietary supplement category and its premarket notification and labelling rules. It defines what may be sold as a supplement and what claims are permitted.
DSHEA compliance determines whether your US launch can proceed without rework.
FDA registration
Listing of a manufacturing facility with the US Food and Drug Administration as required for firms making dietary supplements for the US market. Registration is not an approval and does not certify product safety.
US buyers often require a supplier's FDA registration before requesting samples.
GMP certificate
A certificate issued after an audit confirming that a facility meets Good Manufacturing Practice requirements. It states the scope, the standard applied, and the issuing body.
The certificate's scope must match the dosage form you are buying.
Halal certification
Certification by a recognised body that a product and its production process comply with Islamic dietary requirements. It covers ingredients, cleaning agents, and cross-contact controls.
Middle East and Southeast Asian buyers may not accept a product without it.
Kosher certification
Certification by a rabbinic authority that ingredients, equipment, and processes meet kosher rules. It requires separate production runs or validated cleaning between kosher and non-kosher products.
It expands your addressable market in North America and Israel.
Label claim
The amount of an ingredient stated on the finished product label. It must be supported by batch testing and remain within label-claim tolerance through shelf life.
Overages and tolerances are priced into your formula; unclear claims cause disputes.
Novel food
An ingredient or food not consumed to a significant degree in the EU before May 1997, requiring pre-market authorisation. The status affects whether a formula can be sold in the EU.
A novel-food ingredient can stop an EU launch even if the product is legal elsewhere.
Structure/function claim
A statement that describes how a nutrient affects normal body function, such as 'supports immune health'. In the US it must be truthful, not misleading, and accompanied by a disclaimer.
Claim wording drives label review time and the risk of regulatory challenge.

Commercial terms

Artwork approval
The written sign-off of final label and packaging files before printing and production. It confirms that text, claims, and layout meet the buyer's and the manufacturer's requirements.
Production timelines start only after artwork approval, not after deposit alone.
Bill of materials (BOM)
A list of all ingredients, excipients, and packaging components required to make one batch of a product, with quantities per unit and per batch. It is the basis for costing and procurement.
An incomplete BOM is a common cause of mid-production price changes.
Cost of goods sold (COGS)
The direct cost of producing a unit, including ingredients, packaging, labour, and manufacturing overhead. It excludes marketing, distribution, and retail margin.
COGS sets your floor price and determines whether a SKU is viable at retail.
Deposit
The advance payment, typically a percentage of the order value, required before production begins. It covers raw material procurement and secures the production slot.
Production lead times are counted from deposit and artwork approval, not from PO date.
Ex Works (EXW)
An Incoterm where the buyer takes responsibility for the goods at the seller's premises. The buyer arranges and pays for export clearance, freight, and insurance.
EXW gives you control over freight but adds export-handling work on your side.
Free on Board (FOB)
An Incoterm where the seller delivers goods on board the vessel at the named port. Risk transfers to the buyer once the goods are loaded.
FOB is the most common term for Chinese supplement exports and simplifies cost comparison.
MOQ (minimum order quantity)
The smallest order a manufacturer will accept for a given SKU. It is driven by batch size, packaging minimums, and changeover cost.
MOQ determines your cash outlay and initial inventory risk.
Payment terms
The agreed schedule for paying an order, such as deposit plus balance before shipment. Terms may include letters of credit or net days for repeat buyers.
Payment terms affect your working capital and the supplier's production priority.
Purchase order (PO)
A buyer's written instruction to supply specified goods at an agreed price and terms. It becomes the contract once the supplier confirms it.
A precise PO prevents disputes over quantity, specification, and delivery date.
Tooling cost
A one-time charge for creating custom shapes, moulds, or printing plates needed for a specific product. It is usually separate from the per-unit price.
Tooling is a sunk cost that raises the effective price of small first orders.

Logistics

Air freight
Transport of goods by aircraft, typically used for samples, launch quantities, or high-value low-weight products. It is faster and more expensive per kilogram than sea freight.
Air freight shortens the cash-to-stock cycle for first launches.
Bill of lading (B/L)
A transport document issued by the carrier that serves as a receipt for goods, a contract of carriage, and a document of title. It is required to release cargo at destination.
Errors on the B/L delay cargo release and can trigger demurrage.
Certificate of analysis (COA)
A document reporting the test results for a specific batch, including identity, potency, and microbiological data. It should reference the batch number and test methods.
A COA that does not match the batch on the label will fail importer review.
Commercial invoice
A customs document stating the seller, buyer, goods description, quantity, and value. It is used to assess duties and taxes at import.
Under- or over-valuation on the invoice creates customs risk and delays.
DDP (Delivered Duty Paid)
An Incoterm where the seller delivers goods to the buyer's named place, cleared for import and with duties paid. The seller bears almost all risk and cost.
DDP simplifies your landed cost but usually carries a price premium.
Freight forwarder
A company that arranges transport, customs clearance, and documentation on behalf of shippers. It consolidates cargo and books space with carriers.
A good forwarder is your main defence against port delays and documentation errors.
HS code
The Harmonized System code that classifies a product for customs. It determines the duty rate, import restrictions, and documentation requirements.
A wrong HS code can change your duty rate and trigger customs inspection.
Landed cost
The total cost of goods delivered to your warehouse, including unit price, freight, insurance, duties, and handling. It is the true cost basis for pricing.
FOB price alone can understate cost by 20–40% once freight and duties are added.
Lead time
The period from order confirmation to goods being ready for shipment. It includes material procurement, production, and quality release.
Lead time drives your reorder point and stockout risk.
Sea freight
Transport of goods by container ship, used for full pallet or container quantities. It is slower than air but significantly cheaper per unit for heavy or bulky orders.
Sea freight economics determine whether your retail price can compete.

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