Ferrying medicines & saving lives
Producing medicine is only the first step, procuring it to the required areas is a highly complex transport effort, where lives can be at stake if anything works less than perfectly. We seek expert views on how maintaining a pharmaceutical logistics is se
Logistics of pharmaceuticals is not only a complex, but demanding and often challenging, as temperature is a vital component that needs to be maintained constant. It is crucial to assure the product’s integrity at every point.
explores the distribution practices for maintaining quality and product integrity of temperature-sensitive pharmaceutical products to achieve end-to-end visibility. We also delve into compliance of certifications like IATA CEIV Pharma (the Centre of Excellence for Independent Validators in Pharmaceutical Logistics) and good distribution practices that will help stakeholders in handling pharmaceuticals holistically.
FIRST EXPIRY, FIRST OUT
Vaibhav Vohra, Managing Director, Continental Carriers, believes, “Since the pharma products are highly sensitive to heat, humidity, direct sunlight and other external factors dampening the quality, the handling instructions needs to be explicitly mentioned on the products or packing material while transporting the goods. Attention should be paid to products requiring specific storage conditions and the stock should be rotated
according to the ‘First Expiry, First Out’ (FEFO) principle to maintain the sanctity of the product.” Sharing his experience, he informs, “Appropriate temperature for medicinal products should be maintained during the transportation and storage of the goods as described by the manufacturers or shipper. The handling of the goods must be in a specific way so that the labelling is not lost, sufficient safeguards against leakage, theft, breakage, etc. exists along with the recording/controlling facilities of the critical parameters pertaining to each shipment.”
Rahat Sachdeva, Vice President, Rahat Continental, mentions four practices that play a major role in effective distribution of temperature-sensitive pharmaceutical products, i.e. appropriate packing, moving through the chain, keeping track to stay on track and getting educated and regulated. He continues, “Pharmaceutical companies tend to either over engineer or under engineer packaging. There are two types; active and passive. Active ranges from a separate, individual package and full container to entire trailers and aircraft. Since active packaging relies on its own thermostatic-controlled energy source, the outside temperature generally doesn’t affect products. But external conditions can affect passive packaging, which uses conventional packaging combined with wet ice, gel packs, dry ice, or liquid nitrogen (LN2), depending on the temperature control needed.”
Shankar Iyer, Director (Cargo) India, Middle East & Africa, Swiss WorldCargo, shares, “To maintain quality and product integrity of temperature-sensitive pharmaceutical products, seamless coordination and collaboration among all parties involved is crucial. At Swiss WorldCargo, a first initiative from our side was done through continued investment in our ‘
Attention to products requiring specific storage conditions and the stock should be on the FEFO principle
quality corridors’ or network of certified trade lanes covering global pharma routes. Outside of these trade lanes and of our network, we place importance on all points along the supply chain, especially on the ground.” According to Ajay Khosla, General Manager (NORO), Scorpion Express, “The current pharmaceutical supply chain scenario in India is extremely complex. One of the main reasons for this complexity is the presence of 60,000 plus retail pharmacies which are spread across country but shipment can be transported to these distant areas through poorly connected routes and poor transport facilities, this make cost of drugs much higher than the other developed countries. Presently, the cost of transportation is more than 25-30 per cent of revenue generated by pharmaceutical companies but efficiency of the current system has clearly not been demonstrated, still more than three-fifths of Indians still do not have access to modern medicines. This increase in pharma manufacturing requires need of changeover present way of LSP working and strengthen relationship among LSPs, factories and market places.”
ENSURING EXCELLENCE VIA CERTIFICATION
According to Ramesh Mamidala, CEO, Celebi Delhi Cargo Terminal Management India, “The preparation to achieve these certificates help and push the companies (that seek the certification) to achieve some very stringent standards for facility, processes, systems, training, staff and equipment.” “GDP and IATA CEIV Pharma guidelines both are linked to quality as the objective is to ensure that integrity of the product is maintained throughout the supply chain. Their handling guidelines clearly defines responsibility and accountability of each stakeholder involved in supply chain while the goods are in their custody and during changing hands. These guidelines help to meet customer expectation of compliance, standardisation, accountability, transparency across the supply chain with properly trained
Pharmaceuticals with temperaturesensitive and shelf-life concerns expedient shipping attention
To maintain quality and product integrity, seamless coordination and collaboration among all parties is crucial Dependency on air logistics need additional airports, new regular routes and additional facilities
stakeholders on regulations and standards with adequately equipped facilities. Moreover, IATA’s – Temperature control regulations (TCR) chapter deals with packaging, labelling and handling of temperature control pharmaceutical and health care goods. It would be a win-win situation for the customers and industry if these guidelines are practised and followed,” trusts
Manish T Shah, Managing Director, Magnum Cargo. “IATA has recognised the air transportation industry’s effort to address pharmaceutical manufacturers’ needs by developing CEIV Pharma. This globally recognised and standardised certification for pharmaceutical air shipments ensures that the right processes, people and infrastructure are in place to handle and transport sensitive shipments in compliance with existing international and national regulatory requirements,” tells Sachdeva. “Certifications such as the IATA CEIV Pharma and GDP are important throughout the industry as they provide a ‘stamp of approval’, of sorts, implying that a carrier is able to sufficiently carry out the safe handling and shipping of pharmaceutical products,” feels Iyer. “CEIV clearly addresses the need of the hour of pharma industry in terms providing globally recognised and consistent product handling certifications to ensure more safety, security, compliance and efficiency of goods. GDP is a quality system for warehouse and distribution centers dedicated for medicines. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user,” notes Vohra. “Shipping temperature and time-sensitive pharmaceuticals has always been a tricky issue. As volume in single transactions are not very big to use much of cold chain surface transportation so at still pharmaceutical industry relies and will continue to rely on for some more time on air cargo for its speed and trustworthiness and competence in time sensitivity and temperature-controlled shipments. This increasing dependency on air logistics requires additional airports, new regular routes and additional facilities at airport warehouses, conducive for carried products,” says Khosla. “Certifications such as GDP or the IATA CEIV scheme are hugely beneficial, as finding a direct route is the ideal thing to move temperaturesensitive cargo, but most of time this is not possible, so LSPs do their best to ensure they have the right procedures in place at transit points and visibility at destination, not just at the point of origin. Also, the use of technology also helps reduce the need to dedicate manpower to follow shipments. Real-time reporting of data such as location temperature, humidity or drops can help problems to be identified quickly and react the situation immediately,” he adds. Adds Shah, “However, in spite of these certifications dwell time of product exposed to outside temperature at the airport tarmac at origin, hub and destination, will still remain a challenge which is the major area of concern for
temperature control products. Also, CEIV certification has to still make its presence in India and it is very important that all the stakeholders in handling should be a part of this certification, absence of any one in the supply chain may defeat the purpose.”
EVOLVING TECHNOLOGIES
“In airfreight business, there are several technology-driven solutions available that range from temperature probes to smart GPS RFID tags and to packaging material that even changes the colour when not managed appropriately. Probes have been very popular as the cost is much lower as compared to other technology solutions. However, smart tags are becoming popular and getting cheaper. While probes only facilitate post-delivery analysis, the tags offer real-time measurement and communication which is a lot better if any process corrections need to be made. For surface transport, the Bluetooth-based tags work in tandem with a smart phone being used by the driver who will be alerted to correct when a deviation is about to happen,” elucidates Mamidala. “Opticooler is the latest device which uses compressors instead of dry ice for cooling. In combination with electrical heating, this can ensure a constant inside temperature of between +2 and +30 degrees Celsius. It has both the features of cooling as well as heating which makes it unique. Also, data loggers are adding value to the monitoring process in another peculiar way by recording the temperatures vis-a-vis location so that proper action can be taken at later point of time,” shares Vohra. Sachdeva points few technologies presently being used to monitor temperature:
Electronic temperature monitoring and event logger system for recording and reporting air and/ or product temperatures, with optional facilities for recording and reporting specific events such as door-opening or defrost cycles, and for issuing alarms. Such systems may be user-programmable and may also be remotely monitored via satellite link.
Mapping documented measurement of the temperature and/ or relative humidity distribution within a storage area, including identification of hot and cold spots.
Air temperature monitoring systems and devices should be installed in all temperature- controlled rooms, cold rooms, freezer rooms, refrigerators and freezers used to store TTSPPs. Electronic sensors should be accurate to ± 0.5°C or better. Sensors should be in areas where the greatest variability in temperature is expected to occur within the qualified storage volume and they should be positioned so as to be minimally affected by transient events such as door opening.
Humidity monitoring systems and devices should be used in temperature-controlled rooms that are used to store TTSPPs that require a humidity-controlled environment. Monitoring sensors should be accurate to ± 5 per cent RH and located to monitor worstcase humidity levels within the qualified storage volume.
Temperature and where necessary, humidity alarm systems should be linked to the monitoring system(s) with high and low alarm set points. There should be a visual alarm and preferably an audible alarm, together with automatic telephone dial-up or SMS text warnings to key personnel. Mentioning packaging, tracking and traceability as an important part of pharmaceutical end-to-end supply chain for temperature control goods, Shah says, “Technology like RFID (Radio frequency identification) in use is seen as a way to improve safety and security of the pharmaceutical supply chain.” “Our diverse range of solutions, including our SWISS Celsius Active, SWISS Celsius Passive and SWISS Celsius Passive Solutions products, are designed to help effectively monitor temperatures for global shipments. Our various partners, including Envirotainer, cSafe, Dokasch and vaQtec each play an important role for us in providing oversight and carrying out safe handling,” notifies Iyer.
The preparation to achieve these certificates help and push the companies to achieve some very stringent standards
GDP and IATA CEIV Pharma are linked to quality as the objective is to ensure that integrity is maintained