Short answer
ISO 22716 is the global Good Manufacturing Practice guideline for cosmetics. For eye care it matters more than almost any other category, because the product sits directly next to the eye and microbial control is non-negotiable. Verify three things: the certificate is current and in scope, the plant can show you the underlying GMP system, and it can hand you the document pack your market requires (PIF, SDS, DoC, COA).
A certificate on a website proves nothing by itself. The audit checklist below is what turns a logo into evidence — and it is the single fastest way to tell a real certified eye-care OEM from a trading company with a stock photo.
What ISO 22716 actually covers
ISO 22716 organises cosmetic GMP into eight domains. When you audit an eye-care factory, these are the areas you are really checking:
| GMP domain | What a certified eye-care plant should show |
|---|---|
| Personnel | Trained staff, hygiene protocols, health screening for line workers |
| Premises | Segregated cleanrooms, controlled airflow, separate material and personnel flow |
| Equipment | Validated filling lines, calibration records, clean-in-place procedures |
| Raw materials | Approved-supplier list, COA on intake, quarantine before release |
| Production & traceability | Batch records, lot numbering, one-step backward/forward traceability |
| Packaging & labelling | Print control, label proofing, expiry and batch coding |
| Quality control | In-house lab, microbial limits, preservative-efficacy & stability testing |
| Complaints & recall | Documented procedure, mock-recall capability, CAPA records |
The audit checklist
Print this and work through it on a video or on-site audit. Green flags are specific and verifiable; anything vague is a yellow flag.
| Ask for | Green flag |
|---|---|
| ISO 22716 certificate (PDF) | Issuing body named, scope states cosmetics, valid-through date in the future |
| GMPC certificate | Present if you sell to the US; covers the same GMP system |
| Premises evidence | Cleanroom class stated (e.g. Class 100,000 / ISO 8), layout shows separation |
| Raw-material control | Approved-supplier list + COA on every incoming lot |
| Batch records | Sample batch sheet available, lot traceable to materials and equipment |
| Microbial & stability data | Finished-goods microbial limits + preservative-efficacy test on file |
| Document pack | PIF, SDS, DoC, COA templates ready per market |
| Recall procedure | Written procedure + a demonstrated mock recall |
Why eye care is stricter than face care
Eye-area products are held to tighter microbial limits because the eye is a sensitive route. For patches, masks and creams that sit near the eye, the risks are:
- Microbial contamination — a preservative system that is fine for a body lotion may fail for an eye-area product. Ask for preservative-efficacy (challenge) testing.
- Irritation — near-eye skin is thinner. Formula and substrate choice (hydrogel, biocellulose, non-woven) should be validated for the area.
- Particulates & shape — patch edges and embedded particulates need QC checks specific to eye contact.
A certified eye-care OEM should treat these as routine QC, not as special requests. If they look surprised by the question, that is your answer.
Mapping the certificate to your market
| Market | What ISO 22716 unlocks |
|---|---|
| European Union | Cosmetic GMP aligned with ISO 22716 is required; supports the PIF and CPNP notification |
| United States | MoCRA requires a GMP system for cosmetics; facility registration + product listing |
| United Kingdom | UK GPL aligned with ISO 22716; supports the UK product information file |
| Japan / Korea | Accepted as GMP evidence; local labelling and standards still apply |
| Middle East / ASEAN | Recognised GMP proof; speeds mutual-recognition and import clearance |
Red flags
| Red flag | Why it matters |
|---|---|
| Certificate is a logo, no issuer | Cannot be verified; likely not held |
| Scope excludes your dosage form | Certified for something else, not eye care |
| No in-house microbial testing | Cannot prove eye-area safety lot to lot |
| Cannot produce a PIF/SDS/COA template | You will be stuck at customs or registration |
| No audit access at all | Hides the very system you are buying |
Frequently asked questions
Is ISO 22716 mandatory for eye-care cosmetics?
ISO 22716 is the internationally recognised GMP guideline for cosmetics. The EU requires cosmetic GMP aligned with ISO 22716, and the US MoCRA requires a GMP system for cosmetics. So for an eye-care brand selling into the EU or US, a certified manufacturer is effectively table stakes, not a bonus.
What is the difference between ISO 22716 and GMPC?
GMPC is the US FDA's Good Manufacturing Practice for cosmetics; ISO 22716 is the international GMP standard. They overlap heavily. A factory certified to both covers US and EU expectations. Ask which certificate your target market actually requires, and confirm the scope includes your dosage form.
Can a factory certify my private-label product?
No. Certification is granted to the site and its processes, not to your individual SKU. Your product still needs its own documentation set — PIF for the EU, facility and product listing for the US, plus a batch COA and SDS. A certified factory should be able to produce all of these for you.
How do I verify an ISO 22716 certificate is genuine?
Ask for the certificate PDF showing the issuing body, the scope, and the valid-through date. Reputable certifiers let you confirm issuance. A logo on a website with no issuer and no validity date is not verification.
Does ISO 22716 cover eye patches and eye masks specifically?
ISO 22716 covers the manufacturing system for all cosmetics, including leave-on and rinse-off formats. Eye-area products are held to stricter microbial limits, so a certified eye-care plant should also show preservative-efficacy and microbial testing on finished goods, not just the certificate.
Auditing an eye-care factory?
Send your target market, dosage form and estimated quantity — we reply with formulation advice, the document pack your market needs, and a video or on-site audit slot.
Request a Quotation View Our FactoryRelated: EyeOEM factory capability and certification · how to choose an eye-care OEM · EU CPNP vs US MoCRA
EyeOEM · Eye-Care OEM/ODM R&D & Manufacturing · 2026-09-14 · sales@eyeoem.com