Pakistan Journal of Medical Sciences

Published by : PROFESSIONAL MEDICAL PUBLICATIONS

ISSN 1681-715X

HOME   |   SEARCH   |   CURRENT ISSUE   |   PAST ISSUES

-

Brief Communication

-

Volume 24

January - March 2008

Number 1


 

Full Text
PDF of this Article

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



HOME   |   SEARCH   |   CURRENT ISSUE   |   PAST ISSUES

Professional Medical Publications
Room No. 522, 5th Floor, Panorama Centre
Building No. 2, P.O. Box 8766, Saddar, Karachi - Pakistan.
Phones : 5688791, 5689285 Fax : 5689860
pjms@pjms.com.pk