Planning for Best Practices

New technologies and innovative shipper solutions are supporting
protection for sensitive drugs in transit.

As guidance develops to create standard processes for managing product at all stages of cold-chain distribution, manufacturers of temperature-sensitive medicinals have revised their packaging to reach global destinations cost effectively.
 
New solutions in alternative packaging and distribution tracking are reaching the market with regularity. One driver is heightened regulatory oversight. Manufacturers are being audited for best practices, even as expert committees complete prescriptive guidance for ensuring the safety and efficacy of stored and transported drugs.
 
At the IQPC 8th Cold Chain Distribution for Pharmaceuticals Global Forum, attendees were updated on guidance in development, and audiences provided input on the United States Pharmacopeia’s (USP) General Chapter <1079>, Good Storage and Shipping Practices guidance chapter.
 
USP’s Package Storage and Distribution Expert Committee is finishing guidance content for a December 31 deadline, after which the guidance will by released in the next USP update, said Mary Foster, USP committee chairperson and with Catalent Pharma Solutions. “USP received more responses on this Chapter than any they have received before,” said Foster. The 15-member committee, which includes two FDA officials, has reviewed FDA 483 observations and sought input from agencies globally in revising the USP’s current “U.S. centric” guidance, Foster noted.
 
As companion guidance to Technical Report 39, which describes essential practices for cold-chain distribution, the Parenteral Drug Association (PDA) released this year Tech Report 46, on handling and distribution guidance covering “the last mile.”
 
Practices have to be implemented for covering supply-chain parties that fall outside of FDA review and are otherwise not subject to regulatory oversight. One challenge is ensuring that manufacturers’ product temperature requirements are communicated through the chain so supply partners know whether a temperature breach has occurred, Foster said.
 
“Pharmacies and doctors’ offices are storing the bulk of drugs. That’s a whole segment of the last mile where you are not getting much feedback,” an audience member noted. Rafik Bishara, chairman of PDA’s Pharmaceutical Cold Chain Interest Group, said that gaining pharmacy community involvement is a priority.
“End-users won’t read the USP guidance. Would it not be more helpful to provide information [to this segment] with public service announcements?” another attendee suggested.
 
Tegrant’s Kevin O’Donnell reported on the International Air Transport Association’s (IATA) Chapter 17 regulations, which he helped write as chairman of a cross-industry committee.
“The success of any shipment begins and ends with the shipper. Even downstream, the manufacturer has final responsibility,” O’Donnell said.
 
With the establishment of best practices for handling healthcare cargo in the airline segment, a certified training process for Chapter 17 compliance is needed. Also, industry will look to defining a single auditing process for airlines, O’Donnell said.
“Airlines are getting inundated with audit requests, which are [all] actually quite similar,” he said.
O’Donnell said that some shippers are confused about and have been reticent to use Chapter 17’s new time and temperature label.
 
A voluntary label, it is for use with healthcare products only, and it is generally applied by the shipper when a quality service agreement is in place with the airline. Though not an airline requirement, it is strongly recommended by IATA.
“The label is a tool for reducing risk. It is an alert, but not a cure all. Regulators are starting to look for it,” he said.
 
Exelsius, a UK-based cold chain management consultancy, has developed and delivered the first training course addressing the requirements of Chapter 17. Exelsius founder Tony Wright was joined in the course development and training by O’Donnell, Exelsius announced.
 
Developed under the auspices of IATA’s Training and Development Institute, the course drew a cross-sector audience from pharma manufacturers, airlines, forwarders, and service providers.
 
CONTINUOUS MONITORING
Priority Solutions International (PSI; Swedesboro, NJ) has introduced a solution for continuous cold-chain monitoring, including real-time reporting on cargo’s temperature status and location during transit.
A Thermo Fisher Scientific company, PSI provides third-party logistics for pharmaceutical distribution with a niche focus on high-value biologics and temperature-sensitive clinical supplies.
 
The solution deploys new patent-pending information technology, and handheld scanners with both temperature and GPS capabilities, says Bill Freidel, director of international operations, PSI.
 
Two technologies are used for different shipper applications, in enabling door-to-door shipment tracking. Parcel-sized containers are outfitted with RF-enabled data monitors that are scanned to capture historical shipment history. Large containers are equipped with transmitters that signal real-time temperature and location data as the shipment is en route.
 
 “(In the process of container distribution), the data is available immediately through the carton. There’s no need to open the box, download data to a local PC, or wait two days for a data logger to be shipped back,” Freidel says.
PSI delivers programmed monitors with thermal packaging to the pharma company customer or alternately handles the packaging itself. Tags are programmed to capture the temperature every nine minutes.
 
A global network of PSI employees armed with scanners read the packages as product is delivered to warehouses or clinical trial sites. The pharma customer enters the shipment tracking number at PSI’s web site to access the consignment’s detailed temperature history.
Pharma firms using PSI for managing products’ physical distribution are offered the technology as a “bolt-on” solution. Thermo Fisher’s BioServices and Clinical Services divisions will use the service globally in cases where PSI is the distribution agent, Freidel says.
 
The on-board transmission is designed for large parcels, pallet shippers, or airline RKN containers. Transmitters loaded inside the containers provide continuous monitoring of temperature and location via GPS as the cargo is in transit. The transmitter is programmed to signal the satellite every 15 minutes. Data are sent via a server to PSI’s Web site where customers or PSI’s employees can track the shipments in real time.
 
“Airlines won’t allow us to send a signal when the planes are in flight. The system recognizes the container is in motion, continues to collect the data, and sends it on when the cargo is pulled off the aircraft,” he adds.
“We are managing shipments of high-value clinical trial materials to countries where the complexities of customs can cause unpredictable delays. Our service personnel are monitoring the shipment in three full shifts seven days a week. If the cargo is falling out of temperature range or delayed in transit, they can call the local office to prevent a temperature excursion,” Freidel says.

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