24 April 2014 | News | By BioSpectrum Bureau
Almac says that drug manufacturers face a lot of custom challenges
Singapore: Almac said that Asian clinical trials must adopt highest GMP and GDP standards. Speaking to a news report, Mr Paul O'Connor, vice president of Global Quality at Almac, stated that clinical trials across Asian countries were highly increasing, due to the need to provide medicines for their rapidly growing population.
He stated that pharma firms face a number of challenges in manufacturing, storing and distributing the clinical trial materials in order to adhere to GMP practices.
"Most problems are encountered with customs and duties. The GMP documents with the shipments need to be translated and custom officers regularly open the shipments, without knowing the sensitivity of the material that they are handling. This can be detrimental to temperature sensitive products and can also cause product mix ups," he added.
Mr Paul insisted that companies must bring in their own practices for efficient handling of clinical trial products. GMP hurdles can be overcome by also implementing a regional manufacturing and packing strategy that removes the need for multiple licenses for manufacturing in different countries, he suggested.
The best GMP practices if followed can help in the surfacing of more critical drugs earlier in the market, and can improve wellness of the society.