Stability Budget: Data the Superhero
Can stability data really save the life of your products, and prevent millions of dollar loss to your company?
At the end of a complex pharmaceutical supply chain, a product has seen many forms, labs, cities, containers, boxes, docks, trucks, storage facilities, data loggers and finally one patient. If the product is temperature controlled, how do you know it’s been kept in correct temperature and quality conditions from source of APIs, to manufacture, through multiple legs of distribution to patient? Many companies today haven’t asked themselves this question yet. But the regulators are.
With both European and Unites States Pharmacopeia drafting new guidance on GDP for APIs in 2015, it’s clear the pharmaceutical regulatory landscape is moving toward complete visibility of medicines from raw ingredients through manufacturer, all the way to the patient. Not only are they asking for evidence of temperature control throughout the product lifecycle; they are looking into the integrity of how the data is collected, stored and used for risk-based decisions.
So how do you track excursions along multiple legs of an end-to-end regulated complex supply chain? The answer is… stability budget.
Source: Elpro
