Services / ISO 22716 cosmetics GMP
ISO 22716 cosmetics GMP certification, from $800
For cosmetic manufacturers, contract fillers, packers and warehouses: an on-site audit of your good manufacturing practices against ISO 22716 and a certificate buyers recognise.
From $800Certified by EUROTECH
- Accredited by IAB and INTAQS
- Issuing certificates since 2004
- Online or on-site audits worldwide
- Verify any EUROTECH certificate
What ISO 22716 certification covers
ISO 22716 gives guidelines for good manufacturing practices in the production, control, storage and shipment of cosmetic products. It covers the parts of the operation that affect product quality and safety, from receiving raw materials to dispatching finished goods, and is the reference that most cosmetic brands and regulators use for GMP.
Because the standard is written as guidelines, our audit checks your operations against its practices, and the certificate states conformity with ISO 22716. In the European Union, the Cosmetics Regulation requires manufacture to follow GMP, and compliance with the harmonised standard EN ISO 22716 gives a presumption of conformity.
The audit focuses on the areas where contamination or mix-ups can occur. That means premises and their cleaning, equipment and its maintenance and calibration, raw materials and packaging, production and in-process controls, finished product release, quality control laboratory, handling of out-of-specification results, waste, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation.
- Review of your GMP documentation and quality organization
- On-site audit of production, filling, packing, storage and laboratory
- Batch record review from raw material to release
- Certificate valid for three years, with yearly surveillance audits
- Listing on verify.eurotechcertification.com
Documentation underpins all of this. ISO 22716 expects written procedures for key activities, specifications for materials and products, and records that show each batch was made as intended. The auditor checks that documents are approved, current and available where the work is done.
Manufacturer, filler, packer or warehouse: choosing the scope
The scope depends on what you do. A full manufacturer is audited from formulation production through filling and packing to release. A contract filler or packer is audited on the activities it carries out, with attention to how it receives bulk product and specifications from its customers. A warehouse or distributor is audited on storage conditions, stock rotation, segregation and shipping.
If you outsource part of the process, such as bulk manufacture or laboratory testing, ISO 22716 expects a written contract that defines responsibilities and your control over the subcontractor. The auditor checks those agreements.
Cosmetics companies that also make food supplements or medicinal products face different GMP rules for those lines. If you want broader GMP coverage, see our GMP certification page, which covers good manufacturing practice for other product types.
Private label suppliers should agree with each brand owner who holds which records, so that batch documentation, complaints and recalls can be handled quickly when a question comes from the market.
What drives the price
ISO 22716 certification with EUROTECH starts at $800. Audit time depends on the size and complexity of the operation.
- Number of employees in production, quality and storage
- Product types: emulsions, powders, aerosols, anhydrous products, each with different risks
- Number of production and filling lines
- Laboratory testing in house or outsourced
- Sites and warehouses in scope
- Travel for the on-site audit
We confirm audit days, travel and all fees in a written quote. Complete batch records and current cleaning and calibration records keep the audit short.
Products with higher microbiological risk, such as water-based emulsions without strong preservation, usually take more audit time because environmental monitoring, water systems and microbiological testing are examined in more detail.
How ISO 22716 cosmetics GMP works with us
Step 1
Hygiene and facility review
We review your premises, flows and hygiene rules and confirm the scope of the ISO 22716 audit.
Step 2
Process control
The auditor checks weighing, manufacturing and filling controls and equipment cleaning.
Step 3
Batch and packaging check
Batch records, packaging controls and release decisions are traced end to end.
Step 4
Certificate and surveillance
After the decision you receive the certificate, with yearly surveillance audits.
Cosmetics rules in your markets
We audit ISO 22716 for cosmetic companies in the USA, Europe, Asia and Africa. In the European Union, the Cosmetics Regulation requires GMP, a responsible person for each product and a product information file. In the USA, the Modernization of Cosmetics Regulation Act of 2022 introduced facility registration and product listing with the FDA and directs the FDA to set good manufacturing practice rules for cosmetics. Other markets have their own notification and safety rules.
ISO 22716 certification does not replace these legal duties, but it gives buyers and authorities independent evidence that your manufacturing follows recognised good practice. Brand owners often require it from contract manufacturers before they place products on the market.
Exporters should check labelling and ingredient rules in each destination market. While those are product rules rather than GMP topics, mistakes in them often show up as complaints and recalls, which the GMP system must handle.
What to expect on audit day
The audit is carried out on site. Expect the auditor to start with a walk through the plant, following material flow from receipt to dispatch: how raw materials are quarantined and released, how weighing and dispensing avoid mix-ups, how equipment is cleaned and labelled between batches, how filling lines are cleared before a new product, and how finished goods are stored.
Batch records are then reviewed in detail. The auditor picks a released batch and traces it back to the raw material lots and their test results, the equipment used, the cleaning records and the in-process checks, and forward to the customers who received it.
Hygiene of personnel is observed in practice: gowning, hand washing, and how visitors and maintenance staff are controlled in production areas.
Out-of-specification results are a common topic. The auditor will ask what happens when a test fails: who investigates, how the batch is quarantined, how the decision to reject or rework is made and recorded, and whether the cause was fixed.
Findings are graded and the certification decision rests on the evidence. You receive a written report explaining each finding.
Keeping the certificate
Keep change control, deviations, complaints and recalls under the same discipline between audits. Run internal audits across all GMP areas over the year and review results with management. Surveillance audits look at changes since the last visit, such as new products, lines or suppliers, and at how deviations and complaints were handled.
Water quality, environmental monitoring and pest control records often slip between audits, so keep them on a fixed schedule. They are simple to maintain and among the first records an auditor asks for.
Training should follow changes. When a new product, procedure or piece of equipment arrives, train the people affected and record it, because the auditor checks that training keeps pace with the operation.
Keep supplier approvals current as well.
Questions buyers ask
How much does ISO 22716 certification cost?
With EUROTECH it starts at $800. Employees, product types, lines, laboratory, sites and travel set the final price.
Is ISO 22716 required by law?
In the EU, cosmetic manufacture must follow GMP, and EN ISO 22716 gives a presumption of conformity. Certification itself is voluntary but often required by brand owners.
Does ISO 22716 help with FDA rules?
It supports good practice under US cosmetics rules, including the GMP rules the FDA is directed to set under the Modernization of Cosmetics Regulation Act. It does not replace FDA registration or listing.
Can a contract filler get ISO 22716?
Yes. The scope covers the activities you carry out, such as filling and packing, and how you control what you receive from customers.
Is the ISO 22716 audit done on site?
Yes. Production areas, flows, hygiene and batch records must be seen on site.
What is the difference between ISO 22716 and GMP certification?
ISO 22716 is GMP specifically for cosmetics. Our GMP certification covers good manufacturing practice for other product types, such as food supplements.
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Get a quote for ISO 22716 cosmetics GMP
Tell us your company, sites and the standard you need. We reply with a written quote and the audit plan.
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