Obtaining a bilingual GMP certificate from Iran Food and Drug Administration (IFDA) for the production lines of FDG radiopharmaceutical and the Pars-GalluGEN generator
Production lines of FDG radiopharmaceutical and Pars-GalluGEN generator in Pars Isotope’s Cyclotron Radiopharmaceutical Production and Development Center succeeded in obtaining a bilingual GMP certificate (Persian and English) from IFDA.
The bilingual Good Manufacturing Practice (GMP) certificate, issued in the languages of the country producing the pharmaceutical product and in English, is one of the most valid certificates World Wide. This certificate assures the consumer that the product has met all the quality, health, and safety requirements.
GMP is an international framework for producing products according to global standards. The GMP certificate is specific to organizations and industries active in the fields of food, pharmaceutical, health and cosmetic production, and it is valid in all countries. Businesses that obtain Good Manufacturing Practices certification and follow its requirements must meet particular regulations and standards for the production and packaging of their products. GMP certification assures all consumers that the product they are looking for is healthy and safe. Consequently, businesses that intend to have an effective presence in international markets go for this certificate. The most significant benefit of obtaining the GMP standard and complying with the European Union regulations in relation to production methods and quality assurance is to ensure that the final product meets all the requirements of quality, health and safety.
Obtaining a bilingual certificate specific to the production lines of these two products of Pars Isotope, as the exclusive producer and supplier of diagnostic and therapeutic radiopharmaceuticals in Iran, is a confirmation of compliance of the quality of these products with the framework of health requirements.