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quality assurance

GMP

In 2009 BioCentrum, a part of the Selvita Group, received the first Manufacturing Authorization (MA) for analysis and release of medicinal products. The MA document, granted by the Main Pharmaceutical Inspectorate of Poland (the government institution supervised the GMP Program in Poland), proves that all the activities performed in the Analytical Laboratory are compliant with current GMP regulations given by the European Medicinal Agency. Since 2009 the Analytical Laboratory has been regularly audited by the regulatory officials. On February 2014 BioCentrum received a GMP certificate after positive inspection conducted by the GMP inspectors. Positive results of the GMP inspection confirmed that Selvita complies with the standards and requirements of the GMP in its routine activities and all studies conducted in Selvita Group, are planned, performed, monitored, and reported in accordance with the international quality standards established by the pharmaceutical industry.

MA certificate (.pdf)

GMP certificate