Packaging Forum

Cold Chain Concerns - continued

The regulatory scene Currently, no federal regulations define cold-chain packaging standards. Individual FDA inspectors, however, have begun to write Form 483 citations for temperature violations on the basis of their own subjective notions of how to apply the FDA’s general authority to regulate the safety and efficacy of drugs. FDA is reportedly working on cold-chain requirements, and other groups are working to develop specific guidelines. The PDA’s Pharmaceutical Cold Chain Discussion Group (PCCDG, Bethesda, MD, www.pda.org) posted for comment a draft advisory guidance regarding cold-chain processes and testing more than a year ago. As of 1 January 2005, the document, “Medicinal Cold Chain Guideline,” remains in draft form, according to George Robertson, PhD, PDA’s vice-president of science and technology. A PDA committee is in the final phase of reviewing comments from its technical advisors. The process is lengthy because the guidance is meant to be a ground-breaking document that would, for the first time, spell out cold-chain packaging standards in some detail. The committee is now wrestling with competing notions of how much detail to provide. One school of thought argues for specific standards while other participants believe the document should be left more general, Robertson says. The initial draft contained a lot of field-specific terminology. More explanatory language is being included in the final version because the end result is intended to serve as a practitioner’s document, Robertson says. Robertson expects PDA to issue the guidance sometime in 2005. The work of the United States Pharmacopeia (USP, Rockville, MD, www.usp.org) touches on various aspects of the cold chain. The USP has some mandatory standards pertaining to cold-chain packaging such as the storage and packaging definitions contained in chapters 〈661〉 “Containers” and 〈671〉 “Containers—Permeation.” In addition, it has informational guidelines for controlled thermal packaging in chapter 〈386〉, storage, shipping, and distribution handling in chapter 〈1079〉, and good packaging practices in chapter 〈1177〉. Europe does not have specific cold-chain standards yet, either. The European Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) state only that drugs requiring temperature-controlled storage should be transported by appropriate and specialized means. The PDA discussion group is partnering with Europe’s Cold Chain Committee (C3), which is writing a strong guidance for the continent. Participants hope to harmonize the two efforts with the eventual goal of having a single standard published by the International Conference on Harmonisation (ICH, Geneva, Switzerland, www.ich.org), according to a source close to the PDA group. Radio frequency identification (RFID) and the cold chain RFID is being widely adopted to track and trace all manners of products and is seen as a potential tool for cold-chain management. There is strong interest in RFID. Although McKesson Corp. (San Francisco, CA, www.mckesson.com), the nation’s largest pharmaceutical wholesaler, is not currently using the technology in the cold chain beyond track-and-trace, that scenario could quickly change. McKesson is primarily waiting for RFID-reader technology to improve and prices to decrease, according to Ron Bone, McKesson’s senior vice-president for distribution support. One cold-chain products and solutions vendor, which counts most of the top pharmaceutical companies in the country as customers, is running an RFID cold-chain pilot project. The RF-enabled monitors are placed inside test packages to record temperature and humidity at specified intervals and wirelessly download the data to a Web-accessible database when they pass a reader. Active, self-powered tags (i.e., wireless sensors) are being used in the pilot, but commercial solutions could incorporate passive tags and bar codes as well. The pilot does not feature global positioning, but whenever a tag passes a reader, time and temperature data are transmitted along with location and shipment status (Sensitech, Beverly, MA, www.sensitech.com). Herein lies the benefit of RFID for the cold chain. With near real-time reporting and e-mail alerting of temperature trends inside a package, a distributor can take action if a temperature violation is about to occur. If the maximum allowable temperature has already been breached, the customer can be alerted and a new package can be shipped proactively instead of waiting for the customer to report that the product went bad. Temperature tracking and trip history are completely visible without first having to retrieve and read monitors buried inside shipments. (continued)