The new analytical laboratory of the quality control department was designed and built according to the requirements of Good Manufacturing Practices and the ISO/IEC 17025-2009 and was commissioned in 2011.
The technical competence and objectivity of the researches that are being held by laboratory of the quality control department were certified by the Certificate of Attestation of the State Medicine Service of Ukraine for the right to perform quality and safety control of medicines.
The laboratory of the quality control department performs raw materials quality control, intermediate, technical and finished products control, equipment cleaning and facilities control, monitoring of the manufacturing conditions. Chemical (gravimetric and titrimetric) methods of analysis as well as physical and chemical (gas, liquid, thin layer chromatography, spectrophotometry, conductivity, etc.) ones are used according to the requirements of the State Pharmacopoeia of Ukraine.
Archiving of samples of the produced series of finished products is carried out in accordance with the requirements of GMP. The program of study of the stability of raw materials, intermediates and finished products was also implemented.
The laboratory the quality control department is equipped with modern instruments and outfit produced by leading world companies. Our main analytical tools include:
– gas and liquid chromatographs
– IR Fourier spectrometer
– UV – VIS – spectrophotometer
– modern titrators, pH meters, conductometer and others
– climatic chambers.
All methods used in the laboratory were validated, the equipment was qualified.
High level of education and training of the specialists working in the laboratories of the company allows them to participate in the development of methods of analysis of new products and conducting their validation.