ISO 22716 Certification for Cosmetics Good Manufacturing Practice

ISO 22716 is the international good manufacturing practice (GMP) standard for cosmetic products, and itmad audits cosmetics manufacturers against ISO 22716. itmad operates across the Middle East, Asia and Europe, using local auditors and a travelling team. Certification follows a two-stage audit and results in a certificate valid for three years, kept current by annual surveillance audits. Last reviewed: October 2026.

ISO 22716 in brief

The standard sets out good manufacturing practice for cosmetic products: how they are produced, controlled, stored and shipped so that what leaves the factory is consistently what was specified. It addresses the risks that final-product testing cannot catch, because testing a sample tells a manufacturer about the sample and not about the batch it came from.

Who the standard is for

Customers and supplier programmes sometimes ask for independent proof of cosmetics manufacturing practice. ISO 22716 applies to any organisation that manufactures, fills, packs or stores cosmetic products, including:

• Cosmetic and personal care manufacturers
• Contract and private-label manufacturers
• Perfume and fragrance producers
• Skincare, haircare and colour cosmetics producers
• Fillers, packers and repackers
• Manufacturers exporting to the EU

Why it matters commercially

ISO 22716 is the GMP standard referenced by EU Cosmetics Regulation 1223/2009, so a manufacturer exporting cosmetics to Europe is expected to work to it. Retailers, distributors and private-label clients who want assurance that a contract manufacturer operates to a recognised standard can ask for ISO 22716 certification.

What auditors examine

• PersonnelOrganisational structure, defined responsibilities, training, and hygiene requirements for anyone entering production or storage areas.
• PremisesLayout and flow that separate incompatible operations, surfaces that can be cleaned, controlled access, pest control, and adequate lighting and ventilation.
• EquipmentDesign suited to the product, cleaning and sanitisation procedures, planned maintenance, and calibration of measuring equipment.
• Raw materials and packagingSupplier approval, purchase specifications, acceptance criteria, quarantine and release, and controlled storage.
• ProductionManufacturing and packaging instructions, in-process checks, line clearance between products, batch identification and yield reconciliation.
• Finished productsRelease criteria, retained samples, storage conditions, shipment control, and the ability to bring product back from the market.
• Laboratory controlTest methods, sampling, handling of out-of-specification results and retention of results.
• Deviations and complaintsHandling of out-of-specification product, investigation of deviations, management of complaints and execution of recalls.
• Waste and subcontractingDisposal routes for rejected material, and control of any operation that a third party carries out for the manufacturer.
• DocumentationWritten procedures for every process that affects product quality, with records showing that they were followed for every batch.

Batch traceability

Traceability is the requirement that most often exposes gaps. For any batch on the market, a manufacturer should be able to say which raw material lots went into it, which equipment and personnel were involved, what in-process checks were recorded, and where the finished units were shipped. If a recall becomes necessary, that chain decides whether the manufacturer withdraws one batch or everything it has sold. Auditors test it by picking a batch at random and following it in both directions.

How an itmad audit runs

Stage 1 reviews the documented system, confirms the scope of products and processes covered, and identifies gaps before the main audit. Stage 2 tests the system on site: production and packaging areas, storage conditions, batch records, cleaning logs, training records and traceability in practice.

The certificate cycle

An ISO 22716 certificate from itmad is valid for three years, with surveillance audits in each of the two intervening years and recertification before it expires. The certificate states its scope, including the products covered.

What certification brings

• Independent evidence of manufacturing control for retailers, distributors and brand owners
• Support for exporting to markets that reference EU cosmetics regulation
• Fewer batch rejections and less rework, because problems are caught in process and not at final testing
• Faster, narrower recalls when traceability works
• A documented basis for defending product quality if a complaint escalates

Independence

ISO/IEC 17021-1 does not allow a certification body to design, implement or consult on the management system that it certifies, and itmad does not. itmad provides the audit and the certification decision and, if wanted, a pre-assessment that identifies gaps against ISO 22716 without telling the organisation how to close them.

What itmad delivers

• A Stage 1 report setting out readiness gaps ahead of the main audit
• A Stage 2 report with findings tied to objective evidence
• Nonconformities classified by severity, with defined response timescales
• A certificate of registration stating the certified scope and locations
• The certification mark, under the terms of itmad's mark and seal policy
• Annual surveillance audits and reports for the full three-year cycle

Frequently asked questions

What is ISO 22716?

ISO 22716 sets out good manufacturing practice for cosmetic products: how they are produced, controlled, stored and shipped so that what leaves the factory is consistently what was specified. It addresses the risks that final-product testing cannot catch.

Is ISO 22716 referenced by EU cosmetics regulation?

Yes. ISO 22716 is the GMP standard referenced by EU Cosmetics Regulation 1223/2009, so a manufacturer exporting cosmetics to Europe is expected to work to it.

Why is batch traceability tested in ISO 22716 audits?

Traceability is the requirement that most often exposes gaps. Auditors pick a batch at random and follow it in both directions, from raw material lots through production to where the finished units were shipped.

Who needs ISO 22716?

Any organisation that manufactures, fills, packs or stores cosmetic products: manufacturers, contract and private-label producers, perfume and fragrance producers, fillers and packers, and exporters to the EU. Retailers and brand owners may also ask their contract manufacturers for it.

How does an ISO 22716 audit work?

itmad audits in two stages. Stage 1 reviews the documented system and confirms the scope of products and processes. Stage 2 tests production and packaging areas, storage, batch records, cleaning logs, training records and traceability in practice.

How long does an ISO 22716 certificate last?

An ISO 22716 certificate from itmad is valid for three years, with surveillance audits in each of the two intervening years. Recertification is completed before expiry.