Quality is a key to our business. For this reason, Selvita has established a quality management system that oversees aspects of our processes and meets the requirements of the EU GMP/GLP Guides concerning: traceable documentation, precise SOPs, training programs, internal inspection programs and qualification/validation policy. Our laboratories have been regularly audited by the Polish Regulatory Authorities. To keep up to date with the current GMP/GLP regulations Selvita joined to the Polish Good Laboratory and Manufacturing Practice Programs and received GLP certificate (no 8/2016/DPL), GMP certificate (GIF-IW-400/0377_01_01/04/291/16) and Manufacturing Authorization (096/0377/15).
Our GMP/GLP-certified Laboratories ensure that all services offered by Selvita:
- meet the requirements set by our industry
- possess adequate facilities and equipment
- are conducted by an experienced team of professionals who have relevant expertise in the pharmaceutical industry.
Good Laboratory Practice (GLP)
Selvita joined the national Program of Good Laboratory Practice in 2011. GLP Program associates organizations working according to the international, current GLP standards. Quality assurance system based on the GLP requirements is required by law for non-clinical laboratory studies, to assess the properties of chemical substances in the field of safety and health of humans and the environment. The current GLP certificate (no 8/2016/DPL) granted by the Bureau for Chemical Substances (the competent authority of Poland granting GLP certificates) covers all activities of Selvita’s Analytical Chemistry and Molecular Biology Laboratories, including pharmacokinetic and bioanalytical testing, biochemical and chemical analyses, as well as in vitro tests in the area of cytotoxicity and genotoxicity of chemical substances.
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.