Pharma factories told to renew GMP

ABU DHABI — Local pharmaceutical factories must get their Good Manufacturing Practice (GMP) certificates renewed every year to facilitate procedures for export of drug products, a senior health official has advised.

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By Nada S. Mussallam

Published: Mon 10 Jul 2006, 10:49 AM

Last updated: Sat 4 Apr 2015, 7:09 PM

Breaches will subject these establishments to penalties stipulated in the UAE federal pharmacy law No. 4 of 1983, he cautioned. "Local pharmaceutical factories should seek the ministry's renewal for the GMP certificate every year. Certifying drugs factories will greatly assist manufacturers in terms of facilitating export of locally manufactured medicines to foreign markets," Dr Issa bin Jakha Al Mansouri, Director of the Drug Control Department at the Ministry of Health told Khaleej Times.

He said local drugs factories are internationally and regionally recognised. Most of the locally manufactured medicines are exported to Europe and America.

He clarified that the GMP certificate ensures quality products of pharmaceuticals and compliance of local drugs plants with safety and quality guidelines set by the health ministry.

He said renewal of GMP certificates requires inspection visits to these factories to find out whether they were complying with GMP guidelines set by the ministry to ensure quality and safe medicines. "The ministry monitors the guidelines local factories should abide by. Frequency of inspection visists depends on the volume of business these factories are involved in because some plants have multiple production lines," said Dr Mansouri.

He mentioned there are a total of 15 local factories, out of which six are specialised in drug products, while the rest are involved in manufacturing veterinary medicines, medical devices and food supplements.

The official underlined that areas of inspections at these facilities include hygienic standards, storage conditions and personal training on recent approaches in quality assurance and management. He noted that these factories should also abide by the 'Good Storage and Distribution Practice' to guarantee the safety and efficacy of drug products.

Nada S. Mussallam

Published: Mon 10 Jul 2006, 10:49 AM

Last updated: Sat 4 Apr 2015, 7:09 PM

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