GOOD MANUFACTURING PRACTICE CERTIFICATES CONFIRMED (GMP)
The Agency for Medicines and Medical Devices of the Republic of Slovenia (JAZMP), upon the inspection carried out at the plants for production of medicinal products, renewed the certificates for conformity with the principles of Good Manufacturing Practice (GMP), valid for 3 years, as defined in the Directive 2003/94/EC and Article 111(4) from the Directive 2001/83/EC for solid pharmaceutical forms, tablets and capsules, liquid pharmaceutical forms for internal and external use and the cephalosporin plant.
This GMP inspection as well as the assessment of the pharmaceutical quality system was carried out for the first time to all plants simultaneously, with the Agency for Medicines and Medical devices from the Republic of Slovenia in the capacity of supervisor. It is yet another confirmation of the highest European standards that Alkaloid AD applies in its daily work and they are the basis for obtaining and maintaining the marketing authorizations in the European Union.
Thus Alkaloid AD Skopje is confirmed as a highly professional manufacturer of pharmaceutical products by applying the latest production technologies and business standards, with the sole purpose – efficient and safe medicinal products of high quality.