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Long in the making, could become finalized before the end of the year
The January/February issue of Pharmaceutical Forum, the bimonthly publication of the US Pharmacopeia (Rockville, MD) contains the latest proposed revision of section <1079>, “Good Storage and Transportation Practices for Drug Products.” While there have been (and continue to be) a proliferation of guidelines and regulations for shipping temperature-sensitive biopharma products, <1079> is generally considered the most comprehensive, at least for drugs coming into or going out of the US.
The new version, which updates USP guidance last published in 2006, changes the entire tenor of the document from a list of recommended practices, such as labeling instructions, temperature monitors, and refrigerated or insulated packages, to a set of comprehensive systems: an overall quality management system (QMS), comprising a storage management system (SMS) and a transportation management system (TMS) and an environmental management system (EMS; covering temperature monitoring devices as well as standard operating procedures). There is also a recommendation for a risk management system to assess handling temperature excursions or other potential product damage.
There do not appear to be new, prescriptive guidelines for such industry questions as whether shipping containers can be pre-qualified, or whether temperature monitoring is mandatory for each shipment (and not simply for “mapping” a shipment under typical conditions). But the overall tenor is to put the onus on the manufacturer or its designated contractor to ensure safe delivery, and to have each step documented and validated.
“The chapter recognizes that the pathway from the manufacturer to end user is usually complex and that numerous parties are involved in a series of handoffs,” the document’s introduction reads. “As we have moved from a regional to a global supply chain, it has become more important to adhere to labeled temperature requirements.”
The in-process revision is open for comment for 90 days (until the end of March), and then the USP’s Expert Committee will review and finalize the comments, making the chapter part of USP’s National Formulary (NF) compendium. PC