In 2011 a laboratory of quality control department has started operating at PHARMHIM LTD. The laboratory was designed and constructed in accordance with the requirements of good manufacturing practices and standard of ISO/IEC 17025-2006.
In 2013 a microbiology department for controlling the microbiological purity and bacterial endotoxins became a part of the laboratory and thereby expanded the scope of its certification.
All raw materials are subject to incoming inspection and are allowed into the production only with the permission of authorized staff. The algorithm of acceptance comply with the requirements of developed internal documentation based on GMP, SUST (State Union Standards), Technical conditions.
Laboratory of quality control department performs the control of raw materials, intermediates, unpurified and end products, equipment and facilities cleaning, monitoring of manufacturing conditions.
Sales permit for end products is issued by an authorized person based on the series of analysis.
A constant monitoring of the stability of end products is performed when developing and implementing mass production process.
Cleaning of equipment is being controlled using the methods of detecting microquantities of active substances and disinfectants.
Laboratory of quality control department is equipped with modern tools and equipment produced by leading world brands. Our main analytical equipment include:
- gas and liquid chromatographs;
- FTIR Spectroscopy;
- UV-VIS – spectrophotometer;
- laminar flow hoods;
- modern titrators, pH meters, conductivity meters and others;
- installations for the membrane filtration.
Methods described in the State Pharmacopoeia of Ukraine and other pharmacopoeias in the world are applied in the analysis.
High level of education and professional training of personnel working in the laboratories of the company, allow them to participate in the development of analysis methods for new products and conduct their validation.