Managing Cold Chain Storage and Distribution

When dealing with temperature-sensitive high-value critical products, experience counts - the cold chain management process should include: R&D, sourcing, validation, Standard Operating Procedures (SOPs), storage and warehousing, process management, distribution, transportation, regulatory compliance, training, and monitoring.

Such a complexity of logistics and distribution has often posed a challenge to supply chain managers in the balancing of the stringent requirements of the US Food and Drug Administration (FDA). It entails audit trails for the complete validation and monitoring of temperature-sensitive products - from manufacture, to delivery to patient - with a constant emphasis on cost containment.

The start of the supply chain must always begin with R&D, or the sourcing of raw material supplies. The pharmaceutical industry shake-up has seen some major mergers. With the takeover of Wyeth, Pfizer's CEO, Jeffrey Kindler, explained that the combined company will include "two distinct, but complementary, research organizations," with one specializing in small-molecule compounds and the other in biotechnology drugs. The main attraction of Wyeth is its research and concentration on large molecules, creating a broad and deep pipeline in vaccines, antibodies, proteins, peptides, nucleic acids and other modalities. The announcement by Merck's CEO, Richard Clark, remarked that the merger agreement with Schering-Plough "is about size, it's about the growth of in-line products and it's about diversity from a global standpoint." The focus is on the latter's vaccine pipelines for arthritis and allergy problems.

The third merger is the partnership between Roche and Genentech, where the primary objective was to develop the combined organization to become one of the most effective companies in research in biotechnology. Genentech, in keeping its company name in the US, will continue to focus on developing peptides for biopharmaceutical firms.

Another development is the discussion between GlaxoSmithKline and Stiefel Laboratories, where the takeover will increase the former's revenues by US$3 billion.

Meeting Needs
As the movers and shakers of the industry move into another era of biopharmaceutical products (mostly vaccine-formulated) to better treat and combat new diseases, a different set of requirements in the distribution and transportation of these products is also needed.

The success of efforts against vaccine-preventable diseases is attributable in part to the proper storage and handling of vaccines. Exposure of these vaccines to temperatures outside the recommended ranges can adversely affect their potency and efficacy.

With the allure of revenues and profitability, physicians, surgeons, specialists and hospitals' staff, are often the key audiences that are targeted for product education and training by healthcare companies. This is not so for Logistics Service Providers (LSPs), most of which are untrained in understanding the purpose and nature of these potent treatments for chronic diseases such as arthritis, dementia, diabetes, hyperlipidemia, osteoporosis and cancer. A clear mapping of the methodology to handle these products is often neglected. This means that the possibility of mishandling such transportation and storage is high.

Besides biopharmaceutical products, there is also a growing trend in the receiving and handling of medical diagnostics, consumables, devices and re-agents (which have different temperature requirements), in accordance to their individual unique properties.

Strategic Approach Towards Healthcare Development
The evolution of healthcare focuses on biologics, bio-pharmaceutical and medical diagnostics, involving international companies such as GSK, Novartis, Lonza, Genentech and Roche Diagnostics. There are few global LSPs that have the expertise and the necessary business tools that are required to create a hybrid line of logistics solutions for the emerging healthcare requirements.

In addition, the shift of manufacturing sites from the West to the East has also created an increasing demand for inventory movement within Asia and globally. Such growth, only when supported by the right global operating models, which includes a growth-centric global agenda, will then achieve supply chain efficiency. This is essential since supply chain excellence is directly tied to a company's financial performance.

In reality, many traditional pharmaceutical companies have not been able to catch up with the newer, smaller biotechnology companies - with the latter having effectively reengineered their own supply chains and related infrastructure. Slow supply chain reengineering is often due to an organisation's the strong focus on other aspects of the business such as R&D productivity; training and educating internal staff to physicians to patients; complying regulatory standards; obtaining new drug licenses in various countries to gain entry etc.

With overwhelming operating tasks at hand, it is challenging to focus on growth at a strategic level. A good method is the setting up of a steering committee to carve out a roadmap, especially in emerging markets like Asia. In an efficient supply chain, a top-down approach is necessary to ensure operational excellence.

Cold Chain Logistics - What is it?
Cold chain logistics refers to the movement of temperature-sensitive products from the point of origin to end customers in the best possible quality. With greater emphasis on new drugs that are made of relatively larger molecular structures for better efficacy of treatment, these drugs are often sensitive to environmental changes. Such products require temperature-control and can only accept a certain range of temperature fluctuations during transportation and storage. Maintaining the temperature within the desired range for every shipment is the challenge of cold chain logistics.

Close monitoring at periodic stages is essential and such audits help to identify areas of weakness where logistics professionals can implement and devise the right tools to support and maintain the cold chain from "paddock to plate".

Humidity, Temperature and Environment Monitoring
Present day technological devices can drive full monitoring platforms, which include the management of requirements such as humidity, temperature and environment measurement from wall-to-wall and floor-to-ceiling. In addition, remote monitoring is possible via Global Positioning Systems (GPS), along with online or web-based systems for rapid alert functions. Such technologies, of course do not come cheap.

Facilities operate on strict budgets, while striving to meet industry standards and regulations. There is often a need to decide on whether to invest in additional equipment or a new facility, and if it is time to institute an electronic monitoring capability. Depending on each organization's needs, technology like mobile refrigeration units, incubators, clean/ redressing rooms, dangerous-goods and/or poison-drug storage cabinets, key-lock cage and etc, are just examples of such investments - together with an extensive on-site evaluation to include protocols, validation, Standard Operational Procedures (SOPs), process improvements, etc.

Regulatory Compliance
Ensuring stringent environmental assessment for storage, in compliance with regulatory bodies globally is another complex topic as different countries have their own standards and regulations. In order to maintain the quality of products manufactured, these pharmaceutical companies often design different sets of standards and requirements based on the nature of their products. Such protocols add to the complexity of compliance with transportation and storage activities.

A key checklist for Quality Control (QC) managers, maintenance personnel, disease management teams, nurses, physicians, and pharmacists, includes assessments such as:


• Identifying deficiencies and allowing companies to make informed, calculated decisions to rectify problems.
• Demonstrating due diligence to ensure that the unit operates within the prescribed temperature parameters.
• Achieving compliance with USP 797 temperature guidelines, Joint Commission on Accreditation of Healthcare Organizations (JCAHO) MM.2.20 & EC.6.10 standards, CDC standards, US FDA 21 Code of Federal Regulations (CFR) (Part 11, Part 210, Part 211) guidelines.
• Eliminating vaccine/ medication loss due to compromised storage temperatures.
• Ensuring Process Improvement Programs (POP) as part of a continuous Quality Assurance (QA)/QC effort.

It is critical to undertake complete assessments, and maintain communication between three key parties, namely, healthcare firms, LSPs and regulatory bodies. It is vital to ensure that all compliance requirements are agreeable and are standardized for the purpose of maintaining drug efficacy and timely delivery - from manufacturing sites to patients.

Seamless Cold Chain Transportation
The transportation of cold chain products poses the greatest challenge. Any major movements in handling, adverse weather conditions and shock can result in "upsetting" the products' state of conditions. Using the appropriate packaging materials and careful labeling to indicate the delicate nature of such products will help operators to take extra care when handling these items. In certain long-haul journeys, operators may be required to be equipped with gel packs or dry ice to perform re-icing operations to the products, in order to avoid temperature shock.

Another important factor is the ability to handle large volumes via specially approved containers. These containers are accepted by commercial air carriers that are able to ensure better control of maintaining the temperatures within the acceptable range.

Internationally, many organizations engage third party LSPs to provide flexible air, ocean, customs compliance and logistics solutions for highly perishable products with time-critical delivery from the US and throughout Asia Pacific, Europe and Latin America.

A few specialized third party LSPs are able to provide critical transportation solutions with zero tolerance for service failure. This is in addition to the complete automated customer visibility for complicated temperature-controlled product movement, including cold chain management. With the consolidation of such shipments in larger quantities from different healthcare companies, economies of scale can be achieved - which translates back into cost savings for the companies.

The Need to Innovate
R&D in cold chain logistics, refers to ways and methods to reduce waste (in absolute dollar or time-savings) using innovations. Supply chain professionals need to understand the nature of the product and the supply chain, and also adapt and apply other existing bestpractices.

Such activities are part of continuous improvement practices which encourage an environment to "invent" new logistics methodology or tools for the future. It is through these concerted efforts that LSPs provide value-adds to their existing and/or potential customers, as well as gain market share.

Viable and sustainable Cost Optimization
With increasing globalization and environmental awareness, the constant need to reduce cost and address evolving public health issues is likely to shape the cold supply chain of the future. This should lead to the further integration of many pharmaceuticals and healthcare companies to work closely with global service providers who have the right capabilities. These service providers should be equipped with business tools and skilled professionals to offer both technological expertise and advice on supply chain optimization models, over a sustained period if required.

It is important that the companies are satisfied with their selected LSP's business resourcefulness in consolidating efforts to bundle lower rates for transport distribution (domestically and worldwide). Global transportation involves different modes of movement via air, ocean, truck, rail and possible hybrid modes which combine more than one single mode of transport for a single shipment. Such services allow freight savings as well as shorter lead times.

Consolidation efforts in the arena of global logistics include increasing storage capacity as well as a complete logistics solution; from custom clearance to order management, pickand- pack, repackaging, orders delivery, goods return handling, batch control, labeling and logistics information analysis and reporting.

Understanding the complex pharmaceutical supply chain concept and achieving the lean process of logistics and distribution flow, requires strong strategic planning. Each process, through professional in-depth analysis or with the support of business tools, will reveal areas of either process optimization or waste reduction.

With each stage of improvement or elimination of waste, the combined savings can be significant and may allow cost optimization. The journey is challenging but achieving a complete and lean logistics distribution system will be invaluable to any organization.