By Chris Fore
It is an exciting time for those with an interest in the pharma cold chain. While change may cause uncertainty, for those engaged in the heavily regulated healthcare industry, the ongoing refinement of guidance further clarifies the regulatory requirements for the storage and distribution of temperature-sensitive products.
In 2005, there were seven carriers that had a branded cold chain service. Often the focus was on fresh foods, while healthcare products were hardly mentioned in IATA (International Air Transport Association) perishable cargo regulations. Now, more than 20 carriers have branded cold chain product services, and next year IATA will require the labeling of healthcare shipments.
3 Key Documents To Understand
A lot has happened in just seven years. The most influential event during this period was the 2007 release of the Parental Drug Association Technical Report #39: Revised Guidance for Temperature Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, commonly referred to as TR39. This report was coauthored by the U.S.-based Pharmaceutical Cold Chain Discussion Group and the European-based Cold Chain Committee. Because the majority of pharmaceutical traffic flows between Europe and the United States, TR39, to a large extent, harmonized the qualification of packaging and transportation process. It also defined the obligations of both the shipper and transportation provider with respect to quality and training. TR39 has become a common reference for regulators, WHO, United States Pharmacopeia (USP), and IATA.
IATA Perishable Cargo Regulations Chapter 17 should prove to be just as important to the industry as TR39 because it is a regulation for the 230 IATA member airlines that comprise 93% of air traffic. However, if Chapter 17 is to achieve the same status as that of TR39, it must become more available to manufacturers and forwarders who must then require their selected carriers to comply because, regrettably, IATA is not enforcing it.
Finally, this year the long-awaited publication of Model Guidance for Storage and Transport of Time- and Temperature-Sensitive Pharmaceutical Products as Annex 9 to the WHO Technical Report Series, No.961, 2011 has created a global standard for good distribution practices (GDPs). All three of these documents align, given the cooperation of the WHO, USP, IATA, and PDA (Packaging and Design Association) and the fact that many of the authors were involved in more than one organization.
There Is Still Work To Be Done
Manufacturers continue to refine their requirements and speak of the “end mile” and a holistic approach to quality in the face of increased regulatory focus on distribution and processes down the supply chain. Several new industry guidance documents have or will be published this year, and a rewrite of TR39 is planned. Chapter 17 is ambitious enough in scope, and, with all this activity, there will continue to be gaps between the shipper’s requirements and operational capabilities of the transport service providers.
For the forwarders, the challenge has been to maintain training and service quality at similar levels throughout their networks. For the carriers, they must finish implementing Chapter 17 and face similar training challenges as forwarders. Carriers have made tremendous progress, but it has created even more disparity between carrier service levels. And, many need to further develop their training programs, align their procedures to Chapter 17, and implement other elements of an ISO-based quality system such as corrective and preventative action plans and assessments or audits.
Other gaps appear with subcontractor training requirements. According to TR39, it is the obligation of the carrier or forwarder to ensure subcontractors (agents) meet their level of training and quality. Unfortunately, current GDP requirements for training and quality may not be clearly defined in contracts or service-level agreements. Often, demonstration-based training is ad hoc and undocumented. The instruction may be limited, the content dated, or cold chain training is secondary to dangerous/hazardous goods and security.
Tremendous progress has been made through the harmonization of cold chain guidance. The regulatory oversight and industry requirements continue to increase, and the development of the cold chain ultimately serves us all.
About The Author
Chris Fore is the compliance manager at Envirotainer and is responsible for the Qualified Envirotainer Provider Training and Quality Program (QEP). He was a principal author of IATA Perishable Cargo Regulations Chapter 17 and serves on the Time and Temperature Task Force.