Eventually, temperature-controlled shipping standards will be harmonized internationally. Near term, scrutiny will increase
on every point in the supply chain, including mail order pharmacies. In fact, Ellinger of PakSense predicts, "more tracking
of products throughout the entire cold-chain continuum—including the 'last mile.'" Bill Hingle, director of marketing at Cryopak,
a division of TCP Reliable, agrees, noting that the many variables involved with protecting product to the point of use make
the last mile the weakest link in the cold chain.
Hingle also forecasts a shift from looking at packaging costs alone to considering all expenses related to maintaining products
at the proper temperature during storage and transport. This change in financial tactics will coincide with a move away from
more generic temperature-controlled packaging options to "truly qualified and validated solutions," says Mills of Intelsius.
The stronger emphasis on the big picture will prompt more partnerships among carriers, pharmaceutical manufacturers and distributors,
and logistics providers to proactively monitor the cold chain. As a result, we'll see greater use of smart containers that
can compensate for unexpected events like summer-time temperatures in February in New York City or a diverted flight that
translates into eight extra hours on the tarmac in extreme heat or cold. "You don't want to lose high-value product or product
that's in short supply or critically needed," concludes Payne of Intelleflex.
1. MHRA, "Good Distribution Practice,"
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodDistributionPractice, accessed Jan. 2, 2013.
2. H. Forcinio, Pharm. Tech. 36 (9) 34-36 (2012).
3. A. Montero, P. Mahesh, and K. Maltas, "Case Study: Designing 2–8 °C Shippers for International Shipments from US to Latin
America," presentation at IQPC's Cold Chain & Temperature Management Global Forum (Chicago, IL, 2012).
4. Cardinal Health, "Cold Chain–Refrigerated Tote Qualification,"
http://www.cardinalhealth.com/, accessed Jan. 2, 2013.
Cold-chain management resources
Cold Chain IQ, a sub-group of Pharma IQ, http://www.linkedin.com
Cool Chain Association, http://www.coolchain.org
European Union, “Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03),” http://ec.europa.eu/health/files/eudralex/vol-4/gdpguidelines1.pdf
Health Canada, “Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069),” http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069-eng.php
International Air Transport Association, “Air Transport Logistics for Time and Temperature Sensitive Healthcare Products,
Chapter 17” in Perishable Cargo Regulations, http://www.iata.org/publications/Pages/perishable-cargo.aspx
ISPE, “Good Practice Guide: Cold Chain Management,” http://www.ISPE.org/Publications
Medicines and Healthcare Products Regulatory Agency, “Good Distribution Practice: Guidance and Legislation,” http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodDistributionPractice/Guidanceandlegislation/index.htm#9
Pharmaceutical Cold Chain Interest Group, http://www.pda.org
Temperature Assurance Group, http://www.linkedin.com
USP General Chapter 659, “Packaging and Storage Requirements,” (will be official in USP 37-NF 32 in May 2014), http://www.usp.org
USP General Chapter 1079, “Good Storage and Shipping Practices” (2012), http://www.usp.org
USP General Chapter 1083, “Good Distribution Practices – Supply Chain Integrity,” (being reworked based on comments received
from the Pharmacopeial Forum proposal and a public workshop in May 2012), http://www.usp.org
USP General Chapter 1118, “Monitoring Devices-Time, Temperature, and Humidity” (2013), http://www.usp.org
World Health Organization, “Guidelines on the International Packaging and Shipping of Vaccines,” http://www.who.int/vaccines-documents/DoxGen/H5-CC.htm