System of quality assurance and quality control in Biotika a.s. is built up on the legislative base of European Union (The Rules Governing Medicinal Products in the European Union, Volume 4 of EU Guidelines to Good Manufacturing Practice). In regard to joining the Slovak Republic to union of countries on mutual recognition of GMP requirements and their inspections – Pharmaceutical Inspection Cooperation Scheme (PIC/S), the State Institute for Drug Control in Bratislava assumed the responsibility to perform regular inspections of domestic producers in accordance with the GMP requirements and to publish the conclusions of its inspections in the PIC/S member countries.
Guarantee for quality assurance is the Quality Assurance and Quality Control Section which has an independent position and from the organization point of view it is subordinated to Managing Director of the company. The Quality Assurance and Quality Control Section ensures methodical managing of testing of all starting substances including primary packages and packaging materials, in-process control of intermediates, in-process testing of water systems and clean areas and final testing of finished products.
Biotika a.s. is a holder of Certificate of Suitability of the Monograph of the European Pharmacopoeia, issued by the European Directorate for the Quality of Medicines & Health Care for the finished product Phenoxymethylpenicillin V and Polymyxin B Sulphate and is a holder of HACCP Certificate of L-Cystin.
Biotika a.s. is a holder of the valid GMP Certificates for the manufacture of the following substances and products:
- Penicillins and its derivatives
- Polymyxin B Sulphate
- Sterile penicillin based antibiotics filled into vials
- Sterile non-penicillin based antibiotics filled into vials
- Non-sterile penicillin based antibiotics filled into vials
- Sterile small volume liquids
- Terminally sterilized small volume liquids
- Biological medicinal products – hormones
- Non-sterile suspensions and solutions