Quality control department
Key role of the Quality Control Department in the company's quality system is:
- quality control of all types of raw materials used in production;
- quality control at all stages of the production process according to the technological requirements of the regulations; the exclusion of any deviations in the process by timely corrective action;
- control of sanitary conditions of production;
- studying claims of consumers and distributors;
- testing and verification of analytical quality control methods of the drugs;
- development and validation of analytical methods.
Solution of the above problems corresponds to GMP.
To solve these problems in the division of
Quality Control Departmnt are included:
Analytical laboratory conducts comprehensive quality control of the finished product with the following assays:
- absorption spectrophotometry in the ultraviolet and visible regions;
- capillary viscometers;
- potentiometric determination of pH;
- as well as many other methods listed in the State Pharmacopoeia of Ukraine.
For all the tests is used high quality analytical equipment of leading companies of Europe, USA and Japan; all equipment regularly passes qualification.
Meter titrator 852 Titrando is a unique device that allows you to carry out a coulometric or volumetric titration by Karl Fischer, that allows to determine the water content in the entire range from ppm to 100%, in solid, liquid and gaseous substances.
Laboratory of physical and chemical methods of analysis
Laboratory of physical and chemical methods of analysis also conducts comprehensive quality control of the finished product with the following assays:
- high performance liquid and gas-liquid chromatography;
- infrared spectroscopy;
- liquid and gas mass spectroscopy;
In this laboratory for the first time in Ukraine was applied gas mass spectroscopy for the quality control of raw materials and finished products. Using a mass spectrometer of “ion trap” type helped to fundamentally change the input level control.
Agilent 1100 liquid chromatograph with a mass spectrometer detector Agilent 6420.
Located in the laboratory of physical and chemical methods of analysis of the QCD. It is used for input control of raw materials,control of intermediate products, control of finished products, control of samples and cleaning validation procedures.
Optical emission spectrometer with inductively coupled plasma iCAP 6300 Duo ICP-OES with MFC, manufactured by the Company: Thermo Fisher Scientific.
Located in the laboratory of physical and chemical methods of analysis of the QCD. It is used for input control of raw materials and finished goods control.
4 laboratories of stepwise control in manufacturing workshops
Laboratory stepwise control in manufacturing workshops is equipped with analytical equipment for intermediate and bulk products for quick and quality control in all the control points of technological regulations on the drug.
Microbiological laboratory performs control of raw materials, intermediate and finished products for the following microbiological standards:
- microbiological purity;
- bacterial endotoxins;
- assay of antibiotics;
- abnormal toxicity;
- pyrogene colors.
For all the tests is used high quality analytical equipment of leading companies in Europe, USA and Japan; all equipment regularly passes qualification.
In the state of laboratories of QCD are employed both experienced chemists with years of experience, and young specialists – graduates from leading universities: National Pharmaceutical University, Kharkiv National V.N. Karazin University, National Technical University “Kharkiv Polytechnic University”.
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