ISO 22716 for Eye Care: What the Standard Covers and How to Check a Certificate
Short answer
ISO 22716 is the international standard for cosmetics good manufacturing practice. It does not certify a product, and it does not certify a brand. It certifies a site and a quality system that makes cosmetics consistently.
That distinction is what buyers miss. When you buy under-eye patches or eye cream, you are buying against the standard indirectly — through the manufacturer's system, not through the certificate on the carton.
What ISO 22716 actually covers
The standard is organised around who works in the building, what is in it, how it is run, and what happens when something goes wrong. For eye-care products, most of it lands in the same places.
| Area | What the standard requires | Why it matters for eye care |
|---|---|---|
| Premises | Controlled environment, zoning, cleaning and containment | Eye-area products enter contact with delicate skin; particulate and microbial control is the whole point |
| Personnel | Hygiene, training records, and defined responsibilities | Operator conduct is a documented control, not a rule of thumb |
| Equipment | Calibration, maintenance, and cleaning validation | Emulsification and filling consistency directly determines texture and active stability |
| Quality assurance | In-process checks, release testing, and rejected material control | Determines whether a batch is releasable or held |
| Contract review | Documented agreement on what is being made and to which specification | Prevents the most common complaint: a sample that passed, and a batch that did not |
| Distribution and traceability | Batch identification, storage, and recall procedure | Your recall plan depends on the manufacturer being able to identify a batch |
| Complaints and recalls | Defined handling route and records | A documented route exists before you need it, not during |
ISO 22716 vs. GMPC, CPNP and MoCRA
These four words get mixed up constantly, and the mix-up causes real compliance gaps. They are not the same kind of thing.
| Term | What it is | Who needs it |
|---|---|---|
| ISO 22716 | A standard for cosmetic GMP — a system a manufacturer's site is certified against | The manufacturer |
| GMPC | Good Manufacturing Practice for cosmetics, used as the terminology in many regional regimes | The manufacturer |
| CPNP | The EU portal where a responsible person notifies a cosmetic product before it is placed on the market | The brand, via a responsible person — not the factory |
| MoCRA | The US framework adding cosmetic facility registration and product listing, plus record-keeping and adverse event duties | The facility registers; the responsible party lists |
The practical consequence: a factory certificate will not satisfy a CPNP notification on its own. The notification needs a responsible person, a product formulation and a technical file. What the factory supplies is the production-side evidence.
How to check a supplier's ISO 22716 certificate
Four checks, in order. The first two decide most cases.
| Step | Ask for | Confirm |
|---|---|---|
| 1 | The current certificate and the issuing certification body | The holder name is the company making your product, and the address covers that site |
| 2 | The most recent surveillance audit report | It passed, and it covers your product category |
| 3 | Scope statement on the certificate | It names cosmetics manufacturing, not a related activity |
| 4 | A sample retention and batch record from an actual batch | The traceability promised by the standard exists in practice |
What EyeOEM reports against the standard
The facts below are the ones we will confirm in writing when you ask. Anything not listed here is available on request.
- ISO 22716:2007 (GMPC) certification for the eye-care plant
- ISO 9001 quality management and ISO 14001 environmental management
- 100,000-class GMPC cleanroom across a 20,000 m² production eco-park
- 12 automated production lines, including automated emulsification and filling
- Multi-stage RO plus EDI water treatment
- 20,000+ developed formulas in the in-house library
- On-site or video factory audits, led by the production responsible, with written corrective action
We publish our certification list on the factory page and accept audits before you commit budget.
FAQ
Is ISO 22716 the same as GMP?
GMP is the general principle. ISO 22716 is the standard written for cosmetics specifically. In practice buyers ask for "ISO 22716" or "GMPC" and mean the same system, but ask which document the supplier holds.
Does my brand need its own ISO 22716?
No. The certificate belongs to the manufacturer's site. What your brand needs is a supplier who holds it, plus your own product information file and, in the EU, a responsible person.
If a factory has ISO 22716, do I still need CPNP notification?
Yes. CPNP is a market-entry step for the product, handled by your responsible person. The factory's certificate does not replace it — it supplies part of the evidence behind it.
How long does certification stay valid?
It depends on the certification body and on whether surveillance audits pass. Ask for the current certificate and the last audit date rather than assuming a cycle length.
Can I use a certificate from any country?
The certificate must cover the site that makes your product. Where an issuing body is accredited under a national scheme, ask how the certification was carried out and whether the body is accredited.
Verify before you order. Book an on-site or video audit, or request the certificate set, before paying for tooling.