Advanced Degrees

What Will the New Year Bring?

By Kevin O'Donnell | January 22, 2010

Regulatory changes and guidance expected in 2010

Anyone involved in the manufacture and distribution of time- and temperature-sensitive drugs over the past decade has seen a significant evolution to the process. Manufacturing has gone global, distribution has become more diversified and there has been a surge in the manufacture of new biologic drugs. Guidance and regulations have barely been able to keep up with the growing demand and popularity of these therapies. There has been an increased awareness by industry and additional scrutiny given by federal regulators (FDA and other global regulatory bodies) for more transparency and documentation to support medicinal products in distribution. This includes a seismic shift in attention given to drugs at controlled room temperature (CRT) conditions. Temperature assurance has extending well beyond the traditional boundaries of "cold-chain" - drugs for which temperatures must be maintained between 2-8 C. This move toward greater control of all "temperature-sensitive" drugs is also evident by changes and revisions to existing regulations, guidance and best-practice documents, led by the World Health Organization, the United States Pharmacopeia, and the Parenteral Drug Association, and in regulations proposed by Health Canada and the International Air Transport Association. All have essentially dropped the term "cold-chain" from their respective documents.

Here is a look at some of the suggested changes to regulations and guidance related to time- and temperature-sensitive drugs, and their proposed timelines for 2010.


IATA Chapter 17, Air Transport Logistics for Time- and Temperature-Sensitive Healthcare Products


The International Air Transport Association (IATA), the 230-member airline global trade organization representing 95% of the worlds' air carriers, implemented its 9th Edition of the Perishable Cargo Regulations (PCR) in July of 2009. The extensive overhaul from the previous edition took a holistic approach and includes a section on Quality Agreements, Distribution Processes encompassing separate requirements for shipper, freight forwarder, ground transportation service providers, consignees and, of course, the air carriers. The 9th Edition also gives instructions for the use of the new IATA Time and Temperature-Sensitive Label, designed to suit the needs of all partners within the logistics supply chain and to be used in conjunction with a quality service agreement between the shipper and its supply chain partners. The label underwent a slight modification in October, at the insistence of skittish dangerous goods officials who requested a 45 rotation of the label, lest it not be confused with a dangerous goods label. While some companies have already incorporated the use of the label, the PCR states: "Effective July 1, 2010, all time and temperature sensitive healthcare product shipments should be labeled with the Standard IATA Time & Temperature Sensitive Label." Link.

Health Canada, Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUIDE-0069)

First issued in 2005, this brief guide (the meat of the document is only four pages), caused quite a stir in the industry. It has often been described as ambiguous. The Health Products and Food Branch at Health Canada tried not to make it too restrictive, resulting in broad interpretation by its users. The latest draft revision tries to clear up the vagaries while giving a wide berth for implementation. There is continued focus on monitoring and data management, and additional emphasis on wholesaler storage and distribution, although the details of which were still being held close to the vest by Heath Canada, which made several presentations at industry conferences in the latter half of 2009. Implementation is expected mid-2010. Link.

The Transportation Security Administration (TSA), Certified Cargo Screening Program

Beginning August 1, 2010, all cargo offered for carriage aboard passenger aircraft originating in the U.S. must be screened at the piece level. TSA's approach to 100% screening seeks to reconcile the impacts of the requirement on industry operations with the security needs of passenger air travel. A key component of this strategy is the Certified Cargo Screening Program (CCSP). The CCSP is a voluntary program designed to enable vetted, validated, and certified supply chain facilities to screen air cargo prior to delivering the cargo to the air carrier. The CCSP will create additional screening capacity and provide a practical, effective opportunity for screening to occur on individual pieces of cargo prior to consolidation.

The CCSP is a facility-based program for supply chain entities located within the U.S. Facilities that successfully apply and participate in the CCSP program will be designated as Certified Cargo Screening Facilities (CCSFs) and must adhere to TSA-mandated security standards. Any facility that tenders cargo directly to an air carrier or indirect air carrier (IAC) may apply to become a CCSF. This includes:
  • Manufacturers
  • Warehouses
  • Distribution Centers
  • Third Party Logistics Providers
  • Indirect Air Carriers
  • Airport Cargo Handlers
  • Independent Cargo Screening Facilities

This is applicable only in the U.S. and only those who choose to become a certified cargo screening facility will fall under additional regulatory authority of this agency. Link.


United States Pharmacopeia General Information Chapter <1079>
Good Storage & Shipping Practices

This is the "Queen Mother" of all guidance documents for temperature-sensitive drug products. It was first published in 2005 and hasn't been revised since. It appears that nearly all other regulations and guidance in this segment of the industry hearken back or make reference to <1079>. Mary Foster, Ph.D., USP Packaging and Storage Expert Committee member, has been delicately shepherding this long-awaited revised document. Much has changed in the industry during the past five years and consequently the document has gone through a seemingly endless series of draft revisions in an effort to keep pace. "The biggest change to 1079 is that the document has been put in the context of 'systems'," Dr. Foster said. "There is a section on Quality Systems, Transportation Systems, Environmental Systems, Storage and Risk Management Systems, commensurate with the FDA's current practices for auditing," she added.

The umpteenth and final draft will appear in the Jan./Feb. 2010 Pharmacopeia Forum (Vol. 36(1)). The document will be available for comment for any members of the industry wishing to express their opinions, for a period of 90 days (March 31, 2010). When the comment period closes, the USP Expert Committee on Packaging and Storage will review all the comments and make a determination whether to incorporate them. Barring a major re-write of the document and inserting only minor editorial changes, the approved revision to <1079> could come as early as 3Q10. Link.

Word Heath Organization

In 2009, the WHO organized a pan-industry task force to author a harmonized guidance for the storage and transport of temperature-sensitive therapeutic products. The deliverable, Regulatory Oversight on Pharmaceutical Cold Chain Management, covers everything from storage building construction standards to refrigerated vehicle validation, and from monitoring to data management. The project was led by mit Kartoglu at WHO and orchestrated by Andrew Garnett, who went through all regulatory oversight documents to create the matrix as the backbone of the 27-page guidance.

The draft was completed in August and reviewed by the Experts Committee on Standardization of Pharmaceutical Products (ECSPP) and the Experts Committee on Biological Standardization (ECBS) in late October, 2009. The document was well received by both committees and formal submission and approval is expected late in 2010.

Parenteral Drug Association (PDA)

The Pharmaceutical Cold Chain Interest Group at the PDA has been busy on several fronts, including organizing several small working groups to develop Technical Reports related to distribution. The groups' latest effort, Technical Report No. 46, Last Mile Distribution, is scheduled for release to PDA members in January 2010. In addition, the PCCIG is also working on documents for good distribution practices, handling and storage of physicians samples, and a second revision to its landmark document, Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment. Last revised in 2007, TR 39 will be extended to cover medical devices, nutritionals and diagnostic products, according to Rafik Bishara, chair of the PCCIG.

Kevin O'Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He blogs at Where Cooler Heads Prevail.

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