Volume 14, Issue 3 (Vol-3 2008)                   Horizon Med Sci 2008, 14(3): 49-63 | Back to browse issues page

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Gh.H. Elhami, MR. Maleki. Designing a model of drug quality assurance for Iran. Horizon Med Sci. 2008; 14 (3) :49-63
URL: http://hms.gmu.ac.ir/article-1-435-en.html
1- , Drelhami@gmail.com
Abstract:   (7800 Views)
Background and Aim: Manufacturing substandard and low quality pharmaceutical products will lead to waste of resources with added health risks to public health. Materials and Method: The research was a descriptive and comparative study. 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. Results: Pharmaceutical quality assurance model of USA had two parts without annexes. The first part described the general concepts. The second part was much larger and had eleven subparts. Each subpart included some GMP requirements. The model of EU was based on two parts. The first part, with nine chapters, presented the basic GMP requirements, and the second part, consisted of nineteen annexes, and illustrated the method of GMP implementation on specific areas of production. The model of Australia was very similar to EU model, structurally and contextually. The model of WHO had written the GMP principles in seventeen chapters without annexes. The model of ICH consisted of nineteen chapters and had no annexes. The model of PIC/S was designed as EU model completely. Iran had no pharmaceutical quality assurance model. The comparative study and feedbacks of experts determined the final proposed model for pharmaceutical quality assurance (GMP) of Iran, which consisted of two parts. The first part, chapters, included thirteen chapters and each chapter described isolated parts of GMP principles. Each chapter was divided to some major titles. Overall, the first part (chapters) consisted of sixty-two major titles. The second part of model consisted of sixteen annexes, which illustrated the method of GMP implementation on specific areas of production. Conclusion: 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.
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Type of Study: Original | Subject: Internal Medicine
Received: 2009/03/2

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