Seven Unique Challenges in Maintaining Cold Chain Continuity in Study Sites in Emerging Markets Across the Globe
Pharma IQ presents seven unique challenges in maintaining cold chain continuity in study sites in emerging markets across the globe:
Africa, Asia and Latin America signify key emerging markets for the pharmaceutical industry, but are also hotbeds of activity for counterfeiters.
According to data from the United Nations, as many as three in 10 pharmaceuticals in these regions are fakes and in Asia and Africa between 50 and 60 percent have been found to have APIs above acceptable levels.
Securing the cold chain plays an essential role in combating this, but infrastructure and regulation is less well developed than in the established United States and European markets, presenting a greater challenge to manufacturers and distributors.
2. Maintenance of cold chain conditions in the air and on the ground
The same underdeveloped infrastructure which presents security concerns for the industry also challenges the maintenance of cold chain conditions, as does the unstable power supply which is not a factor in developed markets.
India, viewed as one of the key growth markets, recognised its weak link by improving its provision at major airports – including Mumbai and Hyderabad – but cold chain facilities still present a barrier to the development of the market in the country.
Authorities are now looking at the creation of pharma hubs with stronger position, a model which would suit locations like Singapore, which can act as a gateway to the rest of the Asian market.
3. Planning, adaptability and contingency plans
Supply continuity is vital for the pharmaceutical industry, but the potential politically instability in emerging markets – as highlighted by the unrest in the Middle East over recent months – adds a new dimension to the creation of continuity plans.
Such issues should be accounted for when conducting a critical risk assessment, identifying the controls in place and testing critical responses. Problems which may be relatively simple to address in regions with established cold chains take on a new significance in countries where provision is sporadic and expertise is thin on the ground.
4. Required documentation and deciding on the value of the material
Documentation is becoming an increasingly pertinent part of regulatory compliance, even in emerging markets. Pharmaceutical Commerce's Bio/Pharma Cold Chain Sourcebook noted Canada, Saudi Arabia, Singapore, Malaysia and Argentina all now demand documentation of individual shipments as a requirement of entry.
Under World Health Organisation Guidelines, time and temperature controlled shipments must have monitoring systems providing documentation which can be both stored and accessed.
However, standardisation of even the labelling of cold chain shipments is something which has been lacking until recently and required documentation varies between markets.
5. Regulatory compliance
With eight of the top 10 pharmaceutical products expected to need cold chain storage in 2016, regulators are stepping up their requirements. Yet, ensuring regulatory compliance across a global network of facilities, particularly in emerging markets, remains a challenge.
Better information is being seen as the key to ensuring regulatory compliance, using data logging technology to ensure they meet the tightened shipping requirements being introduced by not just the EU and the United States, but also emerging markets.
6. Improvements in kit design
Cold chain packing is advancing with combined aims of cutting environmental impact, meeting regulatory requirements and ensuring the security of the supply chain.
Packing firm CryoPort highlighted the growing outsourcing of clinical trials as the need for reliable forms of packing, which offer longer-term protection from temperature excursions and do not use dry ice, removing the need for repackaging.
Smaller and lighter packing will also cut the volume of shipment needed, reducing the cost and further adding to the economic benefits which initially attract pharmaceutical companies to emerging markets.
Improvements in kit design are being aided by the expansion of distribution centres, which will remove the need for packaging to be returned to its point of origin.
7. Technology enabling tracking of temperature and location
To provide complete assurance throughout the cold chain and meet regulatory requirements in emerging markets, pharma companies are increasingly turning to track and trace technology.
DHL is among the companies which recently debuted its track and trace technology, claiming to do so in response to the international demand for cold chain facilities.
Sentry is capable of transmitting and recording distribution data on temperature, humidity light and sudden movement, as well as generating heat maps which detail environmental conditions and data on high-crime areas, SearchDataManagement reported.
RFID technology is being touted as having a lot of potential in this area, either through passive tags which can be read at certain points or active tags which submit a periodical signal.
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