Quality Policy

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Quality Policy

It is the mission of the Jagiellonian Center of Innovation to supply complementary top quality services dedicated to entities operating in the life science sector. These actions are aimed at building and constantly expanding the portfolio of clients from the Life Science area and creating favorable conditions for the emergence and development of businesses involved in research and production activities of largely developmental or innovative nature.

Top quality should be understood as:

providing credible research results
providing reliable information as part of advisory services
keeping impartiality and confidence
execution of project work based on applicable guidelines and legal provisions as well as ongoingly upgraded expertise
manufacturing products in accordance with applicable standards and legal provisions
performing work on a timely basis.

The mission of the Jagiellonian Center of Innovation is pursued in particular through:

action compliant with principles arising out of the implemented quality management system based on the requirements of international standards: PN-EN ISO 9001, PN-EN ISO 17025, PN-EN ISO 13485, PN-EN ISO 22716 and GMP requirements defined in the Regulation of the Minister of Health regarding Good Manufacturing Practice
steps taken in accordance with principles arising out of the implemented food safety management system based on HACCP
employing specialists with the appropriate knowledge and qualifications
raising knowledge and qualifications of employees through training and shared experience
use of appropriate quality materials for tests and manufacture
ensuring appropriate infrastructure and work environment
selection of suppliers and subcontractors who meet specific requirements
implementation of the risk management procedure in the design process, test execution and manufacture of medical devices and pharmaceutical products
analysis and fulfilment of legal requirements and other client requirements
implementation of an efficient complaint handling system
effective corrective action
identification of hazards and specification of critical inspection points and actions to reduce food contamination risk.

The Jagiellonian Center of Innovation is obliged to:

fulfill applicable requirements, including requirements of PN-EN ISO 9001, PN-EN ISO 17025, PN-EN ISO 13485, PN-EN ISO 22716 standards, GMP requirements defined in the Regulation of the Minister of Health regarding Good Manufacturing Practice, requirements of the food safety management system based on HACCP, legal requirements and other requirements of concerned parties which our organization undertook to meet
improve its quality management system continuously.

This Quality Policy is subject to assessment in terms of its fitness in the course of the management review and is part of preliminary training for company staff.

Quality Management System – ISO 9001:2015

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.

Quality Management System – ISO 13485:2016-04

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.

Pharmacy, CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

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.

Cosmetics, GOOD MANUFACTURING PRACTICES (GMP) – ISO 22716: 2009

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).

Authorization to manufacture a medicinal product intended for humans – Chief Pharmaceutical Inspector

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 >>>

Food safety management system based on HACCP

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.

Management System – PN-EN ISO/IEC ISO 17025:2018-02 – Accreditation in the Biological Analysis Laboratory

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 >>>