Delivering temperature-sensitive air freight on time, intact and economically is a perennial headache for the healthcare industry. Programme leader Andrea Gruber explains how the International Air Transport Association’s Center of Excellence for Independent Validators in Pharmaceutical Logistics is improving competency, preparedness and collaboration in the cargo community.
The supply chain route for temperature-sensitive goods is a perfunctory aspect of the pharmaceutical industry. Products are made and shipped from Timbuktu to Tokyo and must always reach their destination punctually, undamaged and on a budget.
Despite this, over the years the associated logistics have proved to be one of the links in the chain that is hardest to control, organise and budget for. This is partly due to a host of well-known reasons that include poor paperwork, undertrained staff and rampant pilfering. Bad communication between teams working for different companies in different countries also leads to disorder, as products from factory A are taken by truck haulage firm B to airport C on air cargo line D to airport E in country F to be sold to distributor G, which then uses them to stock hospitals and pharmacies owned by multinational healthcare conglomerate H under the watchful eye of regulatory watchdogs I through L (one for each country, and one who no one is quite sure what they are specifically monitoring). Products often arrive at this point damaged and in much smaller volume than was ordered and paid for, before being sent to airport M in country N, where they can’t legally be sold.
This procedure can be hugely ineffective, especially when speed or flexibility is required, but who is to blame, where do the problems lie and what, crucially, can be done to solve them?
In order to address these issues, the International Air Transport Association (IATA) has announced how it plans to optimise the ways in which temperature-sensitive pharmaceutical products are supplied and delivered.
Cold efficiency
The Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) was created by IATA as “a concentrated effort to improve the level of competency as well as operational and technical preparedness [that] is urgently required to stop the alarming decline of air cargo’s market share of global pharmaceutical product transport.”
According to the air association’s website, “The industry identified a need to build a network of certified pharmaceutical trade lanes that meet consistent standards and assure product integrity. As a result, it is supporting the air transport industry in complying with pharmaceutical manufacturers’ requirements.” But can it achieve these goals and, if not, what are the alternatives?
Andrea Gruber, senior manager (special cargo) at IATA, started her career in transport logistics 15 years ago, and has implemented plans on customs control and risk management over several sectors. As leader of this new programme she must scrutinise the cold chain in order to identify where any break points within it lie.
“Over the past few years the airlines have been really good in developing and implementing solutions for temperature-sensitive products like perishables,” Gruber explains, “but the growing segment of pharmaceuticals – especially with the pharmaceutical industry being heavily regulated with no standardised global certification – meant there was a way for IATA to look into the matter more deeply.”
She goes on to describe how companies are increasingly having to consider levels of emerging risk as regulatory and market pressures, globalisation, advanced technology and the changing expectations of stakeholders are all now directly affecting the air freight industry.
“Compliance is something that is critical today, and especially when looked at as a market force for pharmaceutical companies,” Gruber states. “IATA has a long-standing tradition in developing standards and will be looking at how it can assist by examining every aspect of coaching management.”
Ensuring that the industry can cope with changing demands is what led to the formation of the centre, and Gruber believes it is something that every company should look into. “IATA was approached by the industry to address its needs and to ensure compliance and quality services, so it has been looking at aspects of cold chain since 2007,” she says.
“IATA governance has a dedicated structure that is looking at temperature-sensitive management and has created a Time and Temperature Task Force to define all the processes and operational logistics for temperature-sensitive products.”
The task force develops and maintains standards for the procedures, documentation, cargo handling, packaging and acceptance of healthcare goods, enabling it to maintain the proper functioning of the pharma logistics sector. “IATA was defining its processes and standards, and then during a ground-handling conference in 2013 there was some discussion in the air freight industry around the idea of ‘are we doing enough?’,” Gruber explains. “Data from the industry indicated reliability issues within the air cargo industry, and that was the trigger for IATA to develop the programme.”
The scheme is still young, but Gruber hopes it will lead to a rise in standards and general care, and help airlines and cargo handlers become more confident in reducing waste and increasing employee reliability. “The programme has been piloted with a ground handler in Singapore to demonstrate that investment in infrastructure, people and processes can be done properly,” she says. “Asian airports have been seen as very complex and are usually where exclusions happen; IATA wanted the pilot programme to prove that the industry can react.”
As well as looking at ways to guarantee product integrity throughout the supply chain the scheme will also help stakeholders meet the growing number of national and international regulations. “The industry is heavily regulated and reducing temperature exclusions was one of the main objectives. IATA wants to restore confidence in air cargo as a reliable form of transport for pharmaceuticals.”
The programme is the first of its kind for the pharma cold chain, and IATA publicity understandably highlights standardisation and transparency as key to the ongoing success of its implementation.
A new face
International refrigeration for pharma hasn’t the best reputation. Economic factors and climate change concerns have recently contributed to something of a comeback in popularity for cargo ships, but Gruber and IATA believe that air cargo can still win the day.
Other companies also offer qualifications. The Singapore Logistics Association offers a Specialist Certificate in Cold Chain Management (Pharmaceuticals & Medical Devices) and the Global Cold Chain Alliance Education offers training and development courses and is linked to several industry associations. IATA’s is specifically designed, however, for those who are more tangentially associated to cold chain, rather than in the thick of it. Airport cargo handlers, rather than warehouse mangers and refrigeration experts, are receiving the training: have they been the cause of the problems all along?
“The CEIV applies a multiphase approach that was originally used in a security environment,” reveals Gruber, going on to how explain the programme will run, and how it will provide training and reinforcement. The first phase is preparation. “A product plan is developed with the company to determine whether or not it can actually go through the process,” Gruber explains.
The second phase is an assessment carried out by an independent validator. “This is like a pre-audit, where processes, procedures, operations and training are checked against a specific list that IATA has developed. The outcomes of these findings must be resolved before moving on to the third stage, which is validation.”
“Throughout the process, IATA assists the companies in compliance, and the gaps that are being identified, and the requirements of compliance. The validation phase is the actual audit, again, based on the same checklist and carried out by another independent validator.
“If the outcome is positive, certification might be granted, as long as throughout the process the training is being completed by the responsible person.
“In terms of transparency, the fact that one specific checklist is used for all the certification that is carried everywhere in the world means the programme is a global certification for handling of pharmaceuticals cargo. This is key: certification programmes carried out in different countries are are based on different requirements, even though the regulatory requirements are the same.
“Current regulations are not based on an international standard for assessing or auditing companies in every country, and IATA wanted to avoid having different levels of validation in Europe, or the US. Transparency is key, as it enables IATA to provide visibility to those companies.”
CEIV’s main goal of providing a coherent, international, transparent strategy at raising standards for temperature controlled goods is laudable and does seem to have the requisite infrastructure, but only time will tell if the industry’s battered reputation can be restored.