Establishing Best Practice Qualification Metrics For Smart Shipping Containers
Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.1
The fragile nature of cell therapies requires special consideration with regard to temperature variation and other hazards known to exist in the distribution environment. Well-designed tests and documenting the robustness of transport packaging are essential for ensuring cell viability and function, especially during the clinical trial phases before commercialization.
Not all specialty-packaging companies go through the time and expense of qualifying their packaging products to meet the rigors of transportation. Some do, but only to the extent that they meet basic minimum standards. Others perform to a self-designed standard. All of these practices can lead to inadequate performance and detrimental risk to the products they are intended to protect.
Source: Pharmaceutical Online