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Volume 24 |
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Published by : PROFESSIONAL MEDICAL PUBLICATIONS |
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Brief Communication |
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Volume 24 |
January - March 2008 |
Number 1 |
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Designing a model of drug
quality assurance for Iran
Elhami Gh. H1, Maleki MR2, Tabibi SJ3
ABSTRACT
Objective: To take up the project for designing a Drug Quality Assurance Model (GMP) for Iran.
Methodology: 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.
Results: 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.
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.
KEY WORDS: Drug, Quality Assurance, GMP.
Pak J Med Sci January - March 2008 Vol. 24 No. 1 167-172
1. Elhami Gh. H., MD PhD
Assistant Professor, Faculty of Health Management,
Ahwaz Jundishapur University of Medical Sciences,
Ahwaz – Iran.
2. Maleki MR, PhD
Assistant Professor,
3. Tabibi SJ, PhD
Professor,
2-3: Faculty of Health Management,
Iran University of Medical Sciences,
Tehran - Iran.
Correspondence
Gh. H. Elhami,
Email: Drelhami@gmail.com
* Received for Publication: September 8, 2007
* Revision Received: September 22, 2007
* 2nd Revision Received: October 1, 2007
* Final Revision Accepted: November 30, 2007
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