The Jagiellonian Center of Innovation has implemented a Quality Management System compliant with the requirements of the ISO 9001: 2015 standard in selected areas of the center’s activity, i.e. provision of the service consisting of designing and conducting laboratory research and tests, including those of innovative nature. No exclusions have been applied to the Quality Management System.

In implementing the procedures required by ISO 9001: 2015 we set ourselves the goal of continuously improving the services which we offer to our business partners.

The Jagiellonian Center of Innovation boasts a certificate issued by the Tüv Rheinland certification body attesting that the center has implemented and applies ISO 9001 requirements.

For more information on our Quality Management System please contact:

Ms Jolanta Kaleta, Ph.D., Quality Assurance Department Manager

We look forward to doing business with you.

The Jagiellonian Center of Innovation has implemented a Quality Management System compliant with the requirements of the ISO 13485:2016-04 standard in selected areas of the center’s activity, i.e. design and development, research, quality control and production of inactive medical devices to be applied to the skin and mucous membranes in solid, liquid and semi-liquid form, commissioned by other manufacturers of medical devices.

In implementing the procedures required by ISO 13485:2016-04 we set ourselves the goal of continuously improving the services which we offer to our business partners.

For more information on our Quality Management System please contact:

Ms Jolanta Kaleta, Ph.D., Quality Assurance Department Director

We look forward to doing business with you.

The Jagiellonian Center of Innovation has implemented a Pharmaceutical Quality System, which encompasses Good Manufacturing Practice (GMP) and quality risk management.

These competencies are validated by the GMP Compliance of Manufacturer Certificate, obtained as a result of an inspection that confirms the compliance of manufacturing conditions with GMP requirements.

The certificate issued to the Jagiellonian Center of Innovation includes manufacturing operations in quality control testing, specifically physicochemical tests.

The Jagiellonian Center of Innovation has implemented the GMP requirements in the production of cosmetics in accordance with the ISO 22716 standard. The requirements of this standard have been introduced into the quality management system in order to ensure appropriate production standards, and thus ensure the appropriate quality and safety of manufactured cosmetic products.

The ISO 22716 standard covers: personnel, premises, equipment, raw materials and packaging materials, production, finished product, quality control laboratory, waste, subcontracting, complaint and recall, internal audits and documentation.

The Jagiellonian Center of Innovation meets the requirements of the Regulation of the European Parliament and of the Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products and the Act of 4 October 2018 on cosmetic products (Journal of Laws, item 2227).

Based on Article 38(1) and (2) of the Act of September 6, 2001, Pharmaceutical Law (Journal of Laws of 2021, item 974, as amended) and Article 104 of the Act of June 14, 1960, Administrative Proceedings Code (Journal of Laws of 2021, item 735), the Chief Pharmaceutical Inspector granted a permit to Jagiellonian Innovation Center Ltd. for the manufacturing of a medicinal product intended for humans, with permit number 262/0584/21.

You can find us on EudraGMDP >>>

The Jagiellonian Center of Innovation, meeting the needs of customers from the food sector, including manufacturers of dietary supplements and foodstuffs for special medical purposes, introduced the requirements of the food safety management system based on HACCP (Hazard Analysis And Critical Control Points) to the Quality Management System. The requirements concern the manufacturing process and include storage, production and quality control of manufactured products.

The obligation to implement HACCP procedures results from Art. 5 of Regulation (EC) No. 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.

The food safety management system aims to eliminate or minimize threats affecting the quality and safety of food. Therefore, the Quality Management System in the production area of ​​the Jagiellonian Center of Innovation, originally based on the requirements of the ISO 22716 standard, defining GMP guidelines in the production of cosmetics, has been supplemented with requirements in food production.

The Jagiellonian Center of Innovation in the Biological Analysis Laboratory has implemented a Management System compliant with the requirements of PN-EN ISO/IEC 17025:2018-02 and has received accreditation from the Polish Center for Accreditation No. AB 1879. The scope of accreditation includes biological and biochemical tests of medical devices for the following methods:

• cytotoxicity by extraction method and by diffusion through agar in accordance with the PN-EN ISO 10993-5:2009 standard
• irritation using a method using reconstructed human epidermis – in vitro in accordance with the PN-EN ISO 10993-23:2021-08 standard

By obtaining accreditation, we confirmed the competences of our Biological Analysis Laboratory. We ensure that the research results are reliable and of the highest quality and recognized by the international organization International Laboratory Accreditation Cooperation (ILAC).

When implementing the procedures required by PN-EN ISO/IEC 17025:2018-02, we were guided by the desire to improve our services, increase the credibility of the Biological Analysis Laboratory and gain greater trust of our clients.

See SCOPE OF ACCREDITATION of the Research Laboratory no. AB 1879 >>>

The Jagiellonian Centre of Innovation Sp. z o.o. has received a decision from the Chief Pharmaceutical Inspector regarding an amendment to the manufacturing or import authorisation for medicinal product no. 262/0584/21.
The amendment involves the extension of the authorisation to include microbiological analysis of non-sterile products. This marks another step toward providing comprehensive services for medicinal product manufacturers. The granted authorisation primarily covers testing of finished products as well as starting materials, including active substances used in drug production.

It also confirms compliance with GMP requirements in the scope of the analyses performed, which is crucial for our partners who commission testing of production water (purified water and water for injection) as part of water system qualification and ongoing water monitoring.
Implementing GMP requirements is also essential for clients commissioning:

• environmental monitoring tests,

• testing of packaging materials used in drug production,

• as well as for manufacturers of active pharmaceutical ingredients (APIs).

It is worth noting that the Jagiellonian Centre of Innovation performs microbiological testing for a wide range of clients from various industries, including manufacturers of cosmetics, medical devices, and dietary supplements, conducting research in accordance with specific industry standards.
The implementation of pharmaceutical sector requirements is extremely rewarding and opens up new research opportunities.

Considering that since 2020 the Jagiellonian Centre of Innovation has held an authorisation for physicochemical testing in quality control, it means that it can carry out the full range of tests for medicinal products, active substances, or excipients as part of quality control, in accordance with specifications or pharmacopoeial monographs.
It is also worth noting that the company offers professional services in the area of stability testing as well as the development and validation of analytical methods necessary in the process of drug registration and manufacturing.