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The Cold Facts: Pharma chain monitoring and documentation practices require an upgrade

TORONTO, Ont. -- The push on both sides of the border to ensure tighter accountability for the storage and transpor...

TORONTO, Ont. — The push on both sides of the border to ensure tighter accountability for the storage and transport of pharmaceuticals has shippers in this industry wondering if their current monitoring and documentation processes are adequate for supporting a well-developed cold chain management program.

“When a regulatory agency comes in and asks how do you know your product is being stored properly or that your HVAC system is working properly, you often find that companies don’t have the data to support such questions,” Henry Ames, director of life science strategic marketing for Sensitech Cold Chain Visibility told the Cold Chain Management and Temperature Control Summit held this week in Toronto.

The summit brought together representatives from government, transportation, monitoring product and service providers and pharmaceutical industry shippers and receivers to discuss new issues of concern and ways to deal with them. Canadian Transportation & Logistics was the media sponsor of the three-day event held in downtown Toronto at the end of February.

Two regulations of the Good Manufacturing Practices in Canada require that guidelines and procedures be in place for storage and transportation conditions such as temperature and humidity among others. It is also required that the conditions of transportation and storage prevent any changes to the “potency, purity and physical characteristics” of the drugs being transported and that standard operating procedures and records be available.

Guidelines for temperature control of drug products during storage and transportation were implemented late last year. Similarly south of the border, the publishing of US Pharmacopeia General Chapter <1079> “Good Storage and Shipping Practices at about the same time, has more clearly defined the requirements for the storage, handling and distribution of pharmaceutical products.

“Regulatory guidance is pushing cold chain visibility across the entire supply chain,” Ames said. “Cold chain visibility means having the right product in the right place, at the right time, and in the right condition. It’s the integration of monitoring, tracking and tracing, with an emphasis on driving measurable process improvement.” His company provides validated data acquisition instruments for in-transit, in-process, and in-storage monitoring, validated enterprise software applications providing web-enabled, scaleable data management, exception reporting and data analysis.

Shipping of temperature sensitive articles presents a special challenge because unlike shock, vibration, and other physical hazards, thermal hazards tend to be unique to a given system. And there are many factors that can contribute to thermal variability of a specific trade lane, including carriers, delivery times, service levels and routes.

Ames, whose company also provides consulting services that measure critical cold chain control points and map and analyze cold chains, said shipping and mapping studies can be an important step towards providing important documentation to ensure drugs are being stored, handled and transported according to predetermined conditions. Determining appropriate packaging specifications for a drug product requires an adequate “ambient temperature profile” for the specific trade lane in question.

“When you are collecting data at a more granular level, it allows you to ask much more intelligent questions of your supply chain partners. It enables you to evaluate cold chain performance by carrier,” Ames said.

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