The inspection, conducted by State Ecological Services of Ukraine testified that the laboratory of quality control department at PHARMHIM LTD. complies with all legal requirements for pharmaceutical companies. Head of the drug quality control laboratory of State Ecological Services of Ukraine Andriy Shovkovy said that the laboratory staff have demonstrated technical competence and objectivity of the research. According to the results the laboratory of quality control department at PHARMHIM LTD. has been certified for the right to perform quality and safety control of medicines.
Laboratory of quality control department performs control of raw materials, intermediates, unpurified and end products, controlling also the cleaning of equipment and facilities, monitoring the production conditions. Understanding the importance of providing the population of Ukraine with safe and effective drugs, the company’s management has equipped analytical and microbiological laboratories with modern instruments and equipment produced by the leading world brands. High level of education and training of professionals working in the laboratories of the company, allow them to participate in the development of methods of analysis of new products, and use the methods that determine microquantities of active substances.
– Product quality is ensured at all stages of the process, and the whole team bears the responsibility for it, – says head of quality control department Zhanna Smolko, who is in charge of the division since 2007.
Compliance of laboratories and quality control systems with European and national standards is confirmed by Ukrainian regulators. In 2011 according to the results of inspections the company received the ISO DSTU ISO 9001: 2009 Certificate “Quality Management Systems”. Meeting the requirement provided the official acknowledgement of the high quality of our products and demonstrated compliance with all the requirements of international standards.
Extended certification of the laboratory via the issuance of the Certificate has resulted in the highest level of certification in accordance with GMP international standards for a pharmaceutical company in Ukraine. This allows to not only monitor the quality of the raw materials and products, but also to sign agreements with other organizations to perform laboratory tests on a contractual basis according to our area of certification, – said General Director Viktor Lyashenko.
Certification of the Laboratory is an additional step towards the compliance with international quality standards and as a consequence to the expansion into the European markets.