Designing a model of drug quality assurance for Iran

ABSTRACT

To take up the project for designing a Drug Quality Assurance Model [GMP] for Iran. It is a descriptive and comparative study. GMP models from USA, EU, Australia and Iran, and WHO, ICH and PIC/S were selected for the comparative study. Internet sites and scientific journals were used for data collection. The comparative study determined the primary proposed model. Then, based on Delphi technique, the primary model was evaluated by experts and eventually the final model was designed, for application in Iran. The comparative study and feedbacks of experts determined the final proposed model for pharmaceutical quality assurance [GMP] for Iran, which consisted of two parts. The first part included thirteen chapters consisting sixty-two major titles. The second part consisted of sixteen annexes. Establishment of standards of the final model of GMP in the drug industry could lead to the improvement of quality of national manufactured drugs, hence, promoting the population health levels