Medochemie Bohemia, spol. s r. o.

Quality AssuranceAt Medochemie, we believe that it is our responsibility to determine and follow the most effective and efficient quality processes.Quality Assurance (QA)The quality of our pharmaceutical products is determined by the cumulative influence of factors including the premises, equipment, materials, services and personnel involved directly and indirectly in the manufacturing process.Quality is the collective responsibility of all personnel. Our Quality Policy is achieved by commitment and team effort.Our Quality Assurance Department directs and coordinates the development and maintenance of our quality system. This is achieved by a combination of testing, validating, monitoring and auditing the materials, facilities, systems and procedures. Before our products reach the market, they undergo a series of rigorous process controls and testing, in accordance with EU regulations. We believe that quality is absolutely essential for the long-term sustainability of our company.Good Manufacturing Practice (GMP)At Medochemie, we believe that it is our responsibility to determine and follow the most effective and efficient quality processes, by ensuring that our factories operate in accordance with the current GMP regulations as stated in the EU directives: Rules Governing Medicinal Products in the European Union.Our manufacturing process is clearly defined, controlled at every level and validated to ensure consistency and compliance with specificationsInstructions and procedures are in clear and comprehensive languageOur operators are all thoroughly trainedWe maintain detailed records of all steps and proceduresAny batch can be traced at any time and can be recalled from supply or saleDeviations and causes of quality defects are investigated and appropriate measures are taken in order to prevent recurrenceComplaints are always examined and addressedMedochemie has been granted Certificates of Good Manufacturing Practice from the EU and WHO, as well as from the Pharmaceutical Services of the Ministries of Health of the countries were we operate, after successfully passing the relevant GMP inspections.Additionally, Cyprus is a full PIC/S (Pharmaceutical Inspection Cooperation / Scheme) member which allows GMP recognition between other PIC/S member countries.ISO 13485 - MEDICAL DEVICESMedochemie has been granted ISO 13485:2016 for applying a quality management system for the design, development, manufacturing and distribution of medical devices.You can find our Quality Policy Here