Dubai, UAE, 31 March 2019: Ensuring product quality and integrity in the pharmaceuticals sector was the focus of the discussions at the 6th Annual Middle East Pharma Cold Chain Congress, held on March 19 and 20 in Dubai. Stressing on the importance of Quality Risk Management (QRM) in ensuring product integrity, Wasif Azeem, Director of Quality Operations, Jamjoom Pharmaceuticals, Saudi Arabia, said the cold supply chain plays an important role in managing quality in a product’s lifecycle. Further, he said: “There has been a significant increase in the biopharmaceutical market over the last 15 years, and a crucial element is the product’s integrity.” However, he said, that there are challenges with maintaining the quality of the product. “Having the knowledge on how to handle the product is crucial, which is why we have to establish and undertake specific QRM measures,” he said.

Elaborating on the measures taken by Emirates SkyCargo to maintain the quality of pharmaceuticals while being handled across the cold chain, Julian Sutch, Head, Global Pharma Sales, Emirates SkyCargo, UAE, said: “Every truck is monitored, and if there is any deviation, we can connect with the driver.” Elaborating, he said, the system is also linked to the Dubai Police. “Handover points are crucial to maintaining integrity, and they do involve risk,” he said. However, he added, in the last three years, Emirates SkyCargo has not had a single deviation. In addition to the handover points and transport, sunrays, the exposure to heat, the infrastructure and the amount of money invested all contribute to the quality of the product, he said. “The only way to secure a product is to use an active container, which is expensive,” he said. Hence, it is important to look at stability and packaging and then conduct a risk assessment in order to have a seamless process.

Highlighting another aspect of QRM, Syed Huda, Regional Quality Assurance Director, Roche, UAE, highlighted that technology, the availability of data and training have a crucial role in cold chain management. He said, “In container monitoring systems, the database is something that must be considered.” For instance, he said, if there is a manual recording, then the person logging the data is also responsible for maintaining temperature. This, he said, brings us to training, which is vital, as the person logging the data must also know how to operate and log the data efficiently for later use. Once we have data, Huda added, we can safely conduct trend analysis and audits in order to get information and feedback as to how the system is doing.