Renewal of GMP certificate for production lines of Pars Isotope radiopharmaceutical products by IFDA
According to the inspections of Pars Isotope’s production lines of radiopharmaceutical products by the experts of the Iranian Food and Drug Administration (IFDA), the GMP certificate for the production lines of Pars Isotope radiopharmaceutical products was extended.
GMP is a part of quality management that ensures that products are always manufactured and controlled in compliance with quality standards appropriate to the intended uses and requirements of the manufacturing license, clinical trial license or product specifications. In addition, drug license holders must produce pharmaceutical products, noticing desired usage as well as following legal requirements to ensure the safety, quality and effectiveness of the products. Achieving such a goal requires following the various stages of production based on documentation and monitoring each of the production stages.
Since Pars Isotope is the exclusive manufacturer and supplier of diagnostic and therapeutic radiopharmaceuticals in Iran, this company considers the observance of pharmaceutical requirements and regulations as one of its main duties to guarantee the quality of its products and to provide consumers with high-quality products. The renewal of Pars Isotope’s GMP certificate by the Food and Drug Administration, confirms this.