Quality Control Laboratory
The main tasks of Quality Control Laboratory include:
- control of the production process of the products on the production line, including e.g. cosmetic products and medical devices.
- testing of input production materials and the manufactured products
- performing physical, chemical and microbiological analyses of purified water produced in the Jagiellonian Centre of Innovation
- monitoring microbiological purity of air and surface of the production line
Most of work performed in the Quality Control Laboratory is performed for internal purposes of the Jagiellonian Centre of Innovation, including the production line and Technology Department that offers design services for cosmetic products and medical devices.
Additionally, we offer:
- stability testing of cosmetic products and compatibility testing of mass with package, as per Colip’s guide “Guidelines on stability testing of cosmetic products”
- stability testing of medicinal products and medical devices as per requirements of ICH Q1A
- storage of products in conditioned chambers, in conditions as per the client’s requirements
Stability testing is performed in conditioned chambers from Memmert that offer stable temperature and humidity conditions in the whole chamber space. Additionally, the temperature and humidity in the chambers is monitored continuously be an independent measuring system (RMS) that provides information on conditions in the chambers 24 h a day.
The Laboratory uses different research methods, including:
- Microbiological purity of cosmetics as per the following standards: PN-EN ISO 21149, PN-EN ISO 16212, PN-EN ISO 22717, PN-EN ISO 18416, PN-EN ISO 22718, PN-EN ISO 21150
- Test of preservation system efficiency, as per PN-EN ISO 11930
- Microbiological purity of medical devices and medicinal products as per Polish Pharmacopoeia and European Pharmacopoeia
- Test of preservation system efficiency for medical devices and medicinal products as per Polish Pharmacopoeia and European Pharmacopoeia
- pH analysis and organoleptic assessment of cosmetic products
- determination of total organic carbon (TOC) content in purified water
- determination of proper conductivity of purified water
- determination of nitrate and heavy metal content in purified water using Pharmacopoeia-based methods
Other analyses within the scope of product stability testing are also possible in cooperation with other JCI Laboratories, e.g. with: Laboratory of Mass Chromatography and Spectrometry, Imaging Laboratory, NMR Laboratory and Laboratory of Biological Analyses.
The work of Quality Control Laboratory is organised as per requirements of PN-EN ISO 9001, PN-EN ISO 13485, PN-EN ISO 22716 standards and with requirements of GMP set forth in the Regulation of the Minister of Health on Good Manufacturing Practice, legal requirements and other requirements of the interested parties, to fulfilment of which our organisation is obliged.
Director or the Quality Department
Jolanta Kaleta, Pharm. PhD
She finished her PhD studies in the Pharmaceutical Department of Collegium Medicum UJ. In the Jagiellonian Centre of Innovation, she is responsible for e.g. quality management system, control of process quality for cosmetic products and medical devices manufacturing, and for running the Quality Control Laboratory. She gained her professional experience as a many-year employee of Apiarian and Pharmaceutical Company “Apipol-Farma” Sp. z o.o., working as the Manager for Quality Control and Qualified Person.
Marta Łukasiak – Quality Assurance Specialist
Marta Kocurek – Quality Control Specialist
Natalia Cagara – Junior Quality Control Specialist