Cold Chain Management in China

China's importance within the global pharmaceutical industry is growing. By the year 2013, China is expected to be the third largest pharmaceutical market in the world, as more and more pharma companies are attracted to a market where both clinical trials and drug development are cheaper.

This growth comes at a time when many of the top pharmaceutical products are expected to require cold chain handling. Figures from the Cold Chain Biopharma Logistics Sourcebook 2010 suggested that by the year 2014, seven of the top ten pharmaceutical products will require cold chain distribution.

The Sourcebook also predicts that regulation will increase, which could present challenges for the underdeveloped Asian cold chain market and the growing levels of cross-border transportation.


Industry growth

According to Alen Yan, general manager for World Courier, clinical trials in China can cost 30 per cent less than in the United States, and drug development can be just 10 per cent of the price it would be in the west.

"The biopharma industry in China has exploded by 20 per cent in just the past five years," he added. "But while it may be very cost effective to conduct clinical trials here, practitioners must understand the challenges of doing business in China."

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This growth requires a supporting infrastructure which allows pharmaceutical companies to transport drugs and related equipment in a safe, timely and cost-effective manner.

Particular growth in the cold chain market is expected to be seen in Asia, where the Biopharma Cold Chain Sourcebook 2010 states the market will increase, by 50 per cent on 2008 levels, by 2011. This outstrips worldwide growth of 33 per cent.

Transportation of vaccines, largely for distribution by philanthropic organisations, around the Asian continent was said to be one of the main drivers of this growth.

However, Pharmaceutical Commerce warned that the growth of the cold chain industry "will not necessarily be linear" with the number of vaccines being distributed.

"There are efforts to package vaccines more efficiently to expedite their transportation, and to develop room-temperature versions of some," it explained.

Challenges

Cold chain management in China presents its own challenges. World Courier launched operations in China in 2008, which allow for temperature-controlled transportation between more than 30 of the major Chinese cities.

Henning Voss, director for World Courier, North Asia, described the situation in China as complex, which meant, up until a couple of years ago, the needs of large pharmaceutical companies wishing to operate in China were not being adequately addressed.

"In addition, domestic transport companies do not yet fully understand the many international standards at play in handling these types of shipments," Voss said.

Logistics company DHL has been expanding its operations in China in order to help pharma operators in the country address the challenges presented by "the increasingly sophisticated needs of life science and healthcare customers in Asia Pacific."

The firm opened a 2,000 sq ft temperature-controlled warehouse at Shanghai, Pudong International airport in May 2009. The site added to the company's existing operations in China which included two 2°C  to 8°C cool rooms in DHL's Global Forwarding PVG Airport Warehouse and two more large, air-conditioned warehouses at Waigaoqiao Bonded Areaand Songjiang Jiuting Non-bonded Area.

DHL said that the opening of the warehouse reflected the continued positive growth expected in the Chinese pharmaceutical market.

Steve Huang, managing director, DHL Global Forwarding China, said: "The life science and healthcare industry in China holds its own despite the global economic crisis. We are optimistic that this sector will continue to offer promising growth."

Rules for Airport Cold Chain / Cold-Chain Cargo Handling

A regulation addition promotes cold-chain cargo handling.
By David Vaczek

The airline industry’s Perishable Cargo Regulations address the most difficult-to-predict segment of cold chain transport. The regulations support the pharmaceutical industry’s need for control and visibility in this supply chain area by defining the critical points where lapses most often occur in airport logistics. They also lay out best practices for meeting regulatory agency requirements for temperature-sensitive products.

Chapter 17 specifies rules for healthcare cargo, saying that shippers and carriers should work together to develop a standard operational procedure (SOP). “Pharmaceutical companies go to extraordinary lengths to protect product from environmental hazards, with very expensive packaging,” says Kevin O’Donnell, director and chief technical advisor to industry, Tegrant Corp., ThermoSafe Brands (Arlington Heights, IL). “They
overengineer packaging, because they don’t completely understand what happens after product is surrendered at the airports. 

“The airline segment has long been identified as a weak link in the chain, with significant potential for mishandling and improper storage,” O’Donnell adds. He worked with a crossindustry committee to write the regulation’s additions. “Chapter 17 updates the handling for medicinal products. The regulations describe what the airlines can begin to do to understand the drug industry’s needs for expediting freight in a safe and efficient manner.”

Airlines that commit to handling medicinal products can offer value-added services and earn higher margins for the high-value cargo. Because healthcare products account for a small fraction of airline revenues, however, observers say the established guidance will dissuade some airlines from emphasizing the segment. “There will be carriers that feel this is way too involved for them,” O’Donnell says.

Eric Raemdonck, manager, special cargo standards, International Air Transport Association (IATA; Montreal, Geneva), and secretary of IATA’s Live Animals and Perishables Board (LAPB), says that “the air transport industry has a good understanding of the needs of the healthcare industry. It will increasingly serve this market, especially now that drug manufacturing is spread across several continents.

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“Who else but the air industry can ensure rapid and efficient distribution such as in times of disease outbreaks? ” Raemdonck says. “For some airlines, [the new guidance] translates into offering customers specialized temperature management products and solutions, whereas for others the focus may be elsewhere in the cargo segment.”

Stating that drug firms and airlines share responsibility for the proper handling of packages, Chapter 17 references the World Health Organizations’ (Geneva) guide on good storage practices for drugs. The guide describes GMPs for proper personnel training, storage conditions, and labeling. Controlled conditions must be maintained in transport, with devices for monitoring temperature in transport advised. Container labeling isn’t mandatory, although the regulations note that “an industry-wide acceptance of standard labeling . . . that does not telegraph the contents of the packages would help expedite product movement [and] avoid improper storage.” It would also provide “the best, safest, and surest means of communicating the time/ temperature sensitivity of [healthcare] freight.”

“Drug companies have approached labeling by writing special instructions for handling in the airway bill,” says O’Donnell. “[But] the ground handlers on the ramp don’t see the bill of landing or read the operating procedures. A lot of ground handling is outsourced. You have people working different shifts, for different airlines, for whom English may not be their first language.”

Chapter 17 includes proposed label designs to indicate that container contents are time and temperature sensitive. At its semiannual meeting in Montreal last October, LAPB voted to consider a more definitive labeling format. Packages, for example, could be labeled with a numbering scheme, with numbers representing containers’ temperature requirements. “On this issue, no official decision has been made,” says Raemdonck. “These regulations will help the airlines understand what they are handling so they make the right decisions, such as when making a judgment call,” says Eric Isom, manager of warehouse operations, Sentry Logistic Solutions (Indianapolis). 

At the LAPB meeting, a Time and Temperature Task Force was approved to work with pharma on the regulations. “This Task Force is temporary in nature, and we encourage the healthcare industry to take advantage of this dedicated platform and delegate observers,” Raemdonck says.

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Source: http://www.pmpnews.com/article/new-rules-airport-cold-chain-0