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GMP certification for food and supplement manufacturers, from $1,500

An independent on-site audit of your good manufacturing practices and a GMP certificate that buyers and distributors can check online.

From $1,500Certified by EUROTECH

Pharmaceutical tablet press in a clean production room with stainless surfaces

What GMP certification covers

Good manufacturing practice, or GMP, is the set of controls that make sure products are consistently produced and controlled to the quality appropriate to their use. It covers the conditions of manufacture rather than the product formula: premises, equipment, people, hygiene, materials, processes, documentation, testing, release and complaints.

Our GMP certification is an independent audit of those controls against the GMP requirements that apply to your products. For food manufacturers that usually means the general principles of food hygiene and good manufacturing practice used internationally. For dietary supplement makers selling into the USA it means the current good manufacturing practice requirements for dietary supplements. We agree the reference with you when we scope the audit, and the certificate states it.

The result is a certificate buyers, distributors and retailers can check on our verification portal, which many of them require before they list a product or approve a contract manufacturer.

  • Agreement of the GMP reference that applies to your products
  • Document review of procedures, specifications and batch records
  • On-site audit of production, storage, hygiene and quality control
  • Batch record traceability check from raw materials to release
  • Certificate valid for three years, with yearly surveillance audits

Contract manufacturers and private label suppliers use GMP certification often, because their customers, the brand owners, need evidence before placing products on the market under their own names.

Which GMP, and how it relates to other certifications

GMP is not one single document. Food, dietary supplements, cosmetics and medicines each have their own GMP rules. Cosmetics have a dedicated international standard, ISO 22716, which we certify separately. Medicinal products are subject to GMP rules enforced by medicines authorities, and a voluntary certificate cannot replace their inspections or authorizations.

For food businesses, GMP is the foundation that food safety systems build on. If your customers ask for a full food safety management system, consider ISO 22000, or FSSC 22000 or BRCGS where they require a GFSI-recognised scheme. GMP certification is often the right first step for smaller manufacturers, or the specific evidence a distributor asks for.

GMP combines well with ISO 9001, which provides the management system around manufacturing controls. An integrated audit avoids checking document control, internal audit and corrective action twice.

Distributors and online marketplaces increasingly ask for GMP evidence from supplement and food suppliers. A certificate with a clear scope, the GMP reference audited and an online verification link answers that request quickly.

The audit checks the GMP reference you choose, not every possible GMP rule, so choose the one your buyers ask for.

What decides the price

GMP certification with EUROTECH starts at $1,500. Audit time depends on the size and complexity of your manufacturing.

  • Product type and risk: dry blends, capsules, tablets, liquids or chilled foods
  • Number of production lines and processes
  • Employees in production, quality and storage
  • In-house laboratory or outsourced testing
  • Sites and warehouses, and travel for the on-site audit

We confirm audit days, travel and every fee in a written quote. Complete batch records and current cleaning, calibration and training records keep the audit efficient.

Plants that make both food and supplements, or several dosage forms, usually need more audit time because each process area and its controls are sampled.

How GMP certification works with us

  1. Hygiene and facility review

    Step 1

    Hygiene and facility review

    We agree the GMP reference and scope, and review premises, flows and hygiene rules.

  2. Process control

    Step 2

    Process control

    The auditor checks weighing, manufacturing, equipment cleaning and in-process controls.

  3. Batch and packaging check

    Step 3

    Batch and packaging check

    Batch records, labelling and release decisions are traced end to end.

  4. Certificate and surveillance

    Step 4

    Certificate and surveillance

    After the decision you receive the GMP certificate, with yearly surveillance audits.

GMP rules where you sell

We audit GMP for manufacturers in the USA, Europe, Asia and Africa. In the USA, the FDA sets current good manufacturing practice rules for food, dietary supplements and drugs, and inspects facilities against them. In the European Union, food hygiene regulations apply to food businesses, and medicinal product GMP is enforced by national authorities. Other countries have their own rules and inspection regimes.

Our certificate shows that an independent auditor found your practices in line with the agreed GMP reference at the time of the audit. Your legal duties to the regulators of each market remain in place, and the audit checks that you know what they are.

Exporters of supplements should also check product registration and labelling rules in each destination market, which are separate from GMP but often requested by distributors at the same time.

Some markets also require a free sale certificate or similar document for exported products, issued by authorities rather than certification bodies. These are separate from GMP certification and we point them out where they apply.

What to expect on audit day

The audit is carried out on site. Expect the auditor to follow materials through the plant: receipt and quarantine of raw materials, identity testing, weighing and dispensing, mixing, encapsulation or tableting, filling and packing, in-process checks, finished product testing, release and storage. Line clearance between batches is a frequent topic, because mix-ups are one of the main GMP risks.

Batch records are traced end to end, from a released batch back to raw material lots and test results, and forward to the customers who received it. Deviations, out-of-specification results, complaints and recalls are reviewed for how they were investigated and closed.

Hygiene of personnel, gowning, cleaning of equipment and premises, pest control and water quality are observed and checked against records. Findings are graded and the decision rests on the evidence; you receive a written report explaining each finding.

Supplier control is checked too: how raw material suppliers are approved, what certificates of analysis are required, whether identity testing is done on receipt and how suppliers of high-risk ingredients are monitored over time.

Keeping the certificate

Keep change control, deviations, complaints and supplier approvals running between audits, and run internal audits across all GMP areas each year. Surveillance audits look at what changed since the last visit, such as new products, new equipment or new suppliers, and how deviations were handled.

Training records often fall behind when staff change. Train new staff before they work on production, refresh GMP training regularly and keep records, because the auditor will sample them.

Stability and shelf-life evidence should be kept current when formulations or packaging change, since buyers ask for it and the auditor samples it.

Review complaint trends at least every quarter.

Please note: a EUROTECH GMP certificate is voluntary third-party certification. It does not replace inspections, licences or GMP certificates issued by regulators, such as the FDA in the USA or medicines authorities for medicinal products.

Questions buyers ask

How much does GMP certification cost?

With EUROTECH it starts at $1,500. Product type, lines, employees, laboratory, sites and travel set the final price.

Is GMP certification the same as FDA approval?

No. It is voluntary third-party certification. The FDA does not approve facilities through certification and inspects against its own rules.

Which GMP standard do you audit against?

The GMP reference that applies to your products, such as food hygiene GMP principles or US dietary supplement cGMP. We agree it at scoping and state it on the certificate.

Do you certify cosmetics GMP?

Yes, through ISO 22716, which is the dedicated standard for cosmetics GMP.

Can a GMP certificate replace a medicines GMP certificate?

No. GMP for medicinal products is enforced by medicines authorities, and only they can issue the related certificates.

Is the audit done on site?

Yes. Manufacturing conditions, hygiene and batch records must be seen on site.

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Get a quote for GMP certification

Tell us your company, sites and the standard you need. We reply with a written quote and the audit plan.

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