Quality you can verify
Every batch undergoes multi-stage quality control. Certified processes and compliance with ISO standards, EU requirements, and the European Pharmacopoeia confirm production safety and repeatability.
Quality standards and certification
| Certificate / Parameter | Description |
|---|---|
| ISO 22716:2007 | Good Manufacturing Practice for Cosmetics (GMP). Certificate issued by TÜV SÜD Poland. Covers every stage of production - from raw material receipt to release of the finished goods. |
| ISO 14001 | Environmental management system. Confirmation of our commitment to minimizing the environmental impact of production activities. |
| ISO 13485 | Quality management system for medical devices. Enables the manufacturing of Class I and IIa medical devices in accordance with the MDR 2017/745 Regulation. |
| Own water intake | MG Evolution has its own pharmacopoeial water intake - full control over one of the key ingredients of every cosmetic formula. The water meets the requirements of the European Pharmacopoeia (Ph. Eur.) and the US Pharmacopeia (USP), ensuring formula repeatability and microbiological safety. |
| Clean zones | Production takes place in controlled cleanliness zones with particle and microorganism monitoring. A standard required for medical devices and preservative-free products. |
| Microbiological control | Microbiological testing of every batch carried out in our own laboratories. Includes microbiological purity control, a Challenge Test, and evaluation of the preservation system's effectiveness. |
| No cross-contamination | Production run in a cell-based system helps limit the risk of cross-contamination between successive batches and products. The process is supported by strictly defined cleaning procedures. |
| Formula confidentiality | Formulas are protected through NDAs, data encryption, and restricted-access systems. This ensures the security of intellectual property at every stage of cooperation. |
| Verified suppliers | Raw materials sourced exclusively from audited suppliers with up-to-date MSDS, CoA, and analysis certificates. Regular re-audits of the qualified supplier base. |
| Machine park | Urliński equipment plus our own machinery, regularly calibrated and certified according to a preventive maintenance schedule. Full calibration documentation. |
ISO 22716 - what it means for your brand
The ISO 22716 certificate confirms that every stage of production - from raw material receipt to release of the finished goods - is controlled and documented in accordance with European Good Manufacturing Practice (GMP). The audit is carried out by the independent certification body TÜV SÜD Poland.
For your brand, this means ready-made manufacturing documentation for the PIF, a minimal number of quality complaints, and the ability to enter demanding markets (Germany, France, the UK post-Brexit) without an additional factory audit.
Batch control - step by step
Raw material receipt
Every raw material delivery is verified for compliance with the specification, CoA, and supplier documentation before being released for production.
In-process control
Ongoing measurement of parameters during production: pH, viscosity, temperature, consistency. Deviations from specification hold the batch pending investigation.
Finished product testing
Physicochemical and microbiological testing of every batch. Issuance of a Certificate of Analysis (CoA) for the client confirming compliance with the approved specification.
Retention sample archiving
Every batch is archived as a retention sample for the entire declared shelf life plus 1 year, enabling full traceability.
Need an audit or documentation?
We provide complete GMP documentation for your trade partners and distribution networks.
Contact us