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Quality and certifications

ISO 9001 cosmetic manufacturer: quality, GMP and batch testing

We are an Italian cosmetic manufacturer with an ISO 9001:2015 certified quality management system, and we manufacture according to GMP ISO 22716. Every batch that leaves our plant near Rome is tested, traceable by its code and documented, so you can put your brand on the product with confidence, wherever in Europe or the UK you sell it.

A laboratory pipette dispensing liquid into a glass bottle

Our certifications and the standards we follow

Three different references, to be read for what they are: a certification we hold, a working standard we apply, and a certification in progress.

ISO 9001:2015, certified

Our quality management system is certified to UNI EN ISO 9001:2015 by Dasa-Rägister, certificate no. IQ-0725-03. That means written procedures, clear responsibilities and regular audits by an external body.

GMP ISO 22716, applied

GMP (good manufacturing practice) are the rules for making cosmetics under controlled conditions. We follow ISO 22716: procedures for production, cleaning, testing, handling non-conformities and record keeping. It is the standard referred to by the EU Cosmetics Regulation.

ISO 13485, in progress

We are working towards ISO 13485, the quality standard for medical devices. The process is under way: it is not yet a certification we hold.

Testing on every batch

A batch is the quantity of product made in a single run, with the same raw materials. We test every one, not a sample taken now and then between orders.

  • In-house laboratory: checks incoming raw materials, product in process and finished product against the approved specifications
  • Accredited external laboratories: test every batch, including for heavy metals
  • Batch code: each batch has a code printed on the pack that links it to its raw materials, production and shipment

Testing both in-house and externally costs more than doing it once. We do it because an analysis by an independent laboratory carries more weight, for you and for the retailers, pharmacy chains and marketplaces that sell your product.

Traceability from raw material to shelf

If a customer reports a problem, you need to find out quickly what is in that pack. With the batch code we can reconstruct:

  1. Which raw materials were used, with their batch numbers and suppliers.
  2. When and on which line the product was made and filled.
  3. Which tests it passed, in-house and external.
  4. Who it was shipped to and when, including when we store the goods for you with our logistics and storage service.

Traceability protects you as brand owner too: both Regulation (EC) No 1223/2009 and the UK Cosmetics Regulation require each cosmetic on the market to be identifiable by batch, and the batch number is one of the mandatory items on the label. See our guide to EU cosmetic labelling.

Qualified suppliers of raw materials and packaging

The quality of a cosmetic starts before the plant. We buy raw materials from qualified suppliers who provide technical and safety documentation for every ingredient. When a supplier is new, we assess them before using their materials in production.

For bottles, tubes, cartons and boxes we work with certified suppliers we have known for years. Knowing who prints and makes your custom cosmetic packaging reduces surprises: colours, closures and materials arrive exactly as approved together.

Claims and testing: a neutral assessment

A claim is what you state about the product: “moisturising”, “dermatologically tested”, “for sensitive skin”. Every claim must be backed by adequate evidence.

We entrust the tests behind functional claims to external laboratories chosen according to what you want to state. The people judging the product are not the people making it, so the result is neutral and you can stand behind it with customers and authorities. There is more detail in our guide to cosmetic claims and testing.

Documentation and regulatory support

With in-house expertise and external regulatory experts, we prepare the documentation needed to sell in the European Union, including the PIF (Product Information File) and the safety report, and we carry out the CPNP notification ourselves. For the UK, SCPN notification and the UK Responsible Person are available through partners, as is support for Canada, the USA, Mexico and Australia. All the details are on our EU and UK compliance page.

Confidentiality

We sign a non-disclosure agreement (NDA) before receiving formulas and project details. On request, formulas developed through our custom formulation service stay exclusive to your brand and are never offered to others.

Frequently asked questions

Is ISO 22716 a certification you hold?

No, and we say so clearly: ISO 22716 is the good manufacturing practice standard for cosmetics, and we manufacture according to it. The certification we hold is ISO 9001:2015, issued by Dasa-Rägister (certificate no. IQ-0725-03).

What tests do you run on each batch?

Every batch is tested by our in-house laboratory and by accredited external laboratories, including for heavy metals. A batch is released and shipped only after a positive result.

Can I get the test results for my product?

Yes. On request we send you the ISO 9001:2015 certificate, the safety data sheets (SDS) and the analyses of the batches you are interested in. Marketplaces and retailers often ask for these documents.

Who carries out claim testing?

External laboratories chosen according to the claim you want to make, for example “dermatologically tested”. This keeps the assessment neutral and separate from production.

Are you certified for medical devices?

ISO 13485 is in progress, not yet obtained. Today we make cosmetics, according to GMP ISO 22716 and with an ISO 9001:2015 certified quality management system.

Would you like to see our documents?

Tell us about your project: together with your quote, we send you the quality documents you need.

Keep reading

  • Contract manufacturingCosmetic contract manufacturing in Italy: lab and plant for your formula, from 500 units per SKU to 40,000 a day. NDA and every batch tested.
  • EU and UK complianceEU cosmetics compliance handled for you: CPNP notification, PIF and safety report with regulatory experts, EU and UK Responsible Person via partners.
  • About usRoklar is an Italian cosmetic manufacturer near Rome, since 2015: a 2,000 m² plant, 15 people, up to 40,000 units a day for your brand.
  • Claims and testingCosmetic claims in the EU and UK: the 6 common criteria of Regulation 655/2013, free-from claims, dermatologically tested and nickel tested.