Middle East healthcare supply chain and its regulations
Column by: Juergen Hirsch, general manager of Tranzone Logistics.
Patient safety is the ultimate objective in the healthcare industry. To achieve and ensure this objective, the healthcare industry works closely with the parties involved in bringing the healthcare products from the point of manufacture to the counter/doorstep where they are handed over. Great care is taken to observe all rules and regulations.
The different requirements impacting the healthcare supply chain are: 1. Healthcare industry Standards (GxP etc.); 2. External Quality Standards (ISO 9001, 27001, 13485 etc.); 3. Manufacturer internal quality standards; 4. Government body defined rules and regulations (i. e. FDA, SFDA, MoH).
1) Healthcare industry standards: Within the healthcare industry over the last decade the GxP standards were defined and evolving. According to Wikipedia ‘GxP is a general term for Good (Anything...) Practice quality guidelines and regulations’. In the healthcare supply chain the most relevant practices to be followed are: GSP (Good Storage Practices), GDP (Good Distribution Practices) and GMP (Good Manufacturing Practices).
One example of these practices is the defining of the standards regarding cleanliness or pest control within the warehouse; another is the question of how trucks need to be equipped to transport pharmaceuticals or medical devices. Audits by the manufacturers or regulatory authorities (FDA, SFDA, Ministry of Health etc.) ensure that these practices are followed and applied.
2. External Quality Standards: In order to ensure patient safety, the healthcare multi-nationals are certifying their supply chain (organisations) with following different ISO quality norms. The same expectations are directed from the healthcare multinationals towards the supply chain service providers.
The most relevant ISO quality norms would be: ISO 9001, 27001 and 13485 – additional/different quality norms might apply, depending on the specific niche of the business. Usually GxP and ISO systems are strongly linked and interwoven to have an efficient and robust quality management system in place.
3. Manufacturer internal Quality Standards: Especially the big players within the healthcare industry need to ensure a globally uniform quality and safety standard in their products, operations and services, independent of geographical location or service provider used. Therefore the manufacturers are having additional important requirements defined on top of GxP standards or ISO quality norms. The details of those additional requirements from each other for example in the case of vaccines vs. tablets.
Compliance with those internal quality standards is also monitored by frequent audits and/or regular (KPI) reporting. It is also observed that an intensive exchange between the persons responsible is important to achieve compliance.
4. Government body define rules and regulations: Government bodies responsible for regulating/monitoring the healthcare markets in their assigned area of responsibility are detailing the GxPs as per the local requirements or needs, or enhancing those with additional demands. Areas for those demands could be: temp. control during transportation with temp tales, minimum shelf life to allow importation, humidity requirements etc.
Conclusion: The healthcare supply chain is well regulated. The focus is on patient safety and not on operational efficiency as it is in other industries. It is a challenge to synchronise to build efficient operation and processes around the laid-down rules and regulations. But patients, in the Middle East, can feel safe, as everything is done to ensure products are ALWAYS handled in the correct way.