ISO 22716 : 2007 • GMP for cosmetics manufacturing • Call 1 813 906 8113•Email: iso@caratga.com
Accredited GMP for Cosmetics Program

Get ISO 22716 Certification GMP for Cosmetics

Third-party ISO 22716 certification for cosmetics and personal care manufacturers who export to the EU or the Middle East, supply retail buyers, or want their GMP in order before FDA finalizes its cosmetics GMP rules under MoCRA.

15 GMP sectionsAudited end to end
Cosmetics-specificScoped to your operation
6 to 20 wksTypical to certified
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ISO 22716 : 2007 GMP for cosmetics Independent third-party On-site or remote audits Global market access

AHF & CGA group clients

Tarte Croda Sephora Dermalogica
Why Get ISO 22716 Certification

ISO 22716 is the GMP standard EU retailers, Middle East importers, and US buyers increasingly ask cosmetics manufacturers to meet.

Independently audited ISO 22716 GMP certification is increasingly a condition of market access for retailers, marketplaces, and export markets.

Meet supplier standards of retailers & marketplaces

ISO 22716 GMP compliance is becoming a condition of market access from key retailers and marketplaces

Independent third-party audited program

A third-party audit against all key requirements of ISO 22716, the international GMP standard for cosmetics.

Export market access from a single audit

ISO 22716 is the international framework followed by the EU Cosmetics Regulation, South Korea’s CGMP, and the ASEAN Cosmetic Directive.

About CGA

An independent certification body, built for responsiveness

Carat Global Assurance (CGA) certifies cosmetics manufacturers to ISO 22716 worldwide. Our auditors are senior cosmetics-GMP specialists, and our team is known for fast turnarounds and a real partnership approach — you get a complete proposal within 24 hours and a direct line to the people running your file.

Senior cosmetics auditors

People who audit cosmetics GMP for a living, not generalists.

Proposal in 24 hours

Send us your details and get a complete, scoped proposal the next business day.

A recognized certificate

An ISO 22716 certificate your buyers and regulators accept.

What we check

ISO 22716 certification requirements

ISO 22716 is built on 15 clauses. Here is what an auditor reviews in each.

ISO 22716 clauseWhat it requires
1. PersonnelDefined GMP roles, training records, and personal-hygiene rules.
2. PremisesHygienic zoning, suitable surfaces, pest control, and controlled utilities.
3. EquipmentEquipment that is suitable, maintained, calibrated and cleanable.
4. Raw & packaging materialsApproved suppliers, identity and sampling checks, and status labeling.
5. ProductionManufacturing records, in-process controls, and line clearance.
6. Finished productsRelease criteria, product specifications, and certificates of analysis.
7. Quality control laboratoryTest methods, specifications, and retained samples.
8. Out-of-specification productDocumented handling and disposition of non-conforming product.
9. WastesControlled segregation, storage and disposal of wastes.
10. SubcontractingWritten contracts and oversight of outsourced operations.
11. DeviationsDeviations recorded, investigated, and corrected.
12. Complaints & recallsComplaint handling and mock-recall capability.
13. Change controlChanges that are controlled, documented and approved.
14. Internal auditScheduled internal audits with documented follow-up.
15. DocumentationControlled SOPs and complete, traceable records.
Certification Process

From gap assessment to acquiring an ISO 22716 GMP certificate.

A clear, supported path. Most facilities certify within 6 to 20 weeks depending on size and readiness.

1

GMP gap assessment

Our technical experts evaluate your current operation against every ISO 22716 requirement and flag the gaps.

2

System development & implementation

You implement against the gap report. It lists every finding by ISO 22716 clause, so your team knows exactly what to build and in what order.

3

Pre-audit readiness review

A dry run under real audit conditions so nothing catches you out on audit day.

4

Certification audit

Pass the formal audit and receive your ISO 22716 GMP certificate.

ISO 22716 readiness checklist

See exactly where your facility stands before the audit — a clause-by-clause checklist you can run today.

Download the checklist
Why choose CGA

One audit covers your ISO 22716 GMP requirement, and Halal, Non-GMO or Vegan in the same visit when you need them, so your team spends fewer days on audits.

Sector-specific auditors

CGA’s ISO 22716 audits are conducted by auditors qualified in cosmetics and personal care manufacturing.

Single audit for global compliance

Aligned to ISO 22716 and global GMP expectations, so a single audit supports multiple commercial and regulatory needs.

An independent audit, clearly scoped

We understand the challenges quality and regulatory professionals face. That’s why we promise prompt communication, clear answers, and dedicated support every step of the way.

Transfer to CGA

Already certified elsewhere? Switching is simple

Moving your ISO 22716 certification to CGA is easier than most teams expect. We review your current certificate and audit history, honor your existing cycle where possible, and manage the transition so there is no gap in coverage — with the responsive service CGA is known for.

We honor your cycle

No need to restart — we pick up where your current certificate leaves off.

No coverage gap

A managed handover so your certification stays continuous.

White-glove onboarding

One point of contact who owns your transfer end to end.

Bundle & save

Combine multiple certification programs in a single audit visit

Combine ISO 22716 with other certification programs to cut audit days, reduce disruption, and open more markets in a single visit.

Markets

Halal Certification

Access international halal consumer markets with accredited third-party halal certification

Clean label

Non-GMO Verification

Align with clean-label and natural product requirements.

Dietary

Gluten-Free Certification

Meet rising demand from gluten-intolerance and celiac consumers with third-party certification

Plant-based

Vegan Certification

Appeal to plant-based buyers with third-party validation.

FAQs

Frequently Asked Questions

Is ISO 22716 certification mandatory for cosmetic manufacturers?

It is not a universal legal mandate, but it is the recognised GMP benchmark for cosmetics (referenced by the EU Cosmetics Regulation) and is increasingly required by retailers, marketplaces, and export markets. In practice it has become a condition of market access.

How long does it take to get certified with CGA?

It depends on facility size and readiness. Most facilities certify within 6 to 20 weeks, covering the gap assessment, system implementation, readiness review, and audit.

Do we need a full GMP system in place before starting?

No. CGA begins with a gap assessment that identifies the gaps for you (or a separate consultant) to close, so you can start from wherever you are today.

What are the most common reasons companies fail ISO 22716 audits?

Weak documentation and records, gaps in cleaning and sanitation validation, poor raw-material and supplier control, and missing deviation or CAPA processes.

What is the difference between ISO 22716 and ISO 9001?

ISO 9001 is a general quality management standard. ISO 22716 is Good Manufacturing Practice written specifically for cosmetics, covering production, control, storage, and shipment.

What documentation is required for ISO 22716?

SOPs for critical operations, batch and production records, training and hygiene records, supplier and raw-material controls, calibration and cleaning logs, and CAPA and complaint records.

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Learn more about the ISO 22716 GMP Certification Program

Tell us about your facility and we’ll scope an ISO 22716 certification that gets you market ready.

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