ISO 22716 explained: what a GMP certificate actually proves

ISO 22716 is the international Good Manufacturing Practice standard written specifically for cosmetics. It is not a formula standard and not a safety standard — it is a standard about process discipline.

It covers personnel and training, premises and equipment, raw material and packaging control, production, finished product control, storage, handling of out-of-specification product, waste, subcontracting, deviations, complaints, recalls, documentation and internal audits.

The practical translation: every batch should be made the same way, by trained people, from controlled materials, with a written record you can reconstruct afterwards. That is the whole promise. It is a narrower promise than most brands assume, and a more useful one.

EU Regulation 1223/2009 requires cosmetics placed on the EU market to be manufactured in compliance with good manufacturing practice, and it points to the harmonised standard — ISO 22716 — as the way to demonstrate it.

That single link is why the standard travels well outside Europe too. Buyers in the Gulf, in Eurasia and across Latin America increasingly ask for it, not because their own regulation names it but because it has become the common language of supplier audits.

Certification is not legally mandatory everywhere. But if you plan to sell into the EU, the absence of a GMP-compliant manufacturer becomes your problem, not the factory's, because the responsible person on the product is you or your importer.

Four things are on every real certificate and all four are worth checking.

The number and the issuing body. Certificates are issued by accredited certification bodies, and the body's own accreditation can be verified. A certificate with no issuing body named is a graphic, not a certificate.

The validity date. Certificates expire, typically on a three-year cycle with surveillance audits in between. An expired certificate on a live website is a maintenance failure at best.

The scope statement. This is the line almost nobody reads and the one that matters most. It names the activities and product categories covered — for example design, production, import and export of cosmetic and cleaning products. A factory certified for leave-on skin care is not automatically certified for the rinse-off product, the hygiene product or the aerosol you want. Match the scope line against your own product before you go further.

It does not prove your product is safe. Safety is established by a product-specific safety assessment written by a qualified assessor, and by the information file behind it. GMP proves the product was made consistently; it says nothing about whether the formula should exist.

It does not prove your claims. "Reduces wrinkles in 28 days" needs its own substantiation. No manufacturing certificate covers it.

It does not replace registration. Notification in the relevant portal, labelling compliance and market-specific requirements sit with whoever places the product on the market.

A factory that tells you its GMP certificate handles all of the above is either confused or selling you something it will outsource.

Ask for the certificate PDF rather than a screenshot, check the scope line against your product category, and confirm the validity date. On a significant order, verify the number directly with the issuing body — it takes minutes.

Then ask for the artefacts the standard requires: a redacted batch record, a certificate of analysis, the deviation procedure. A GMP-certified factory produces these without hesitation because it generates them for every batch anyway. Hesitation is the finding.

Our own facility is certified to ISO 22716 GMP and ISO 9001, with the certificate numbers, issuing bodies and downloadable PDFs published on the certifications page — including the scope line, so you can check it against your product before you ask us anything.