ISTA Pharma Committee Releases USP Stimuli Article
‘Reusable Passive Thermal Packaging System: Best Practice Guideline,’ provides specific guidance on the types of materials used, the qualification of a reusable system, the return logistics and refurbishment service management, and refurbishment and inspection details.
The new ISTA Pharma Committee (established in 2019), formerly known as the Industry Guidance Task Force (established 2017), is currently comprised of representatives from the pharmaceutical/biotech industry and suppliers of passive thermal packaging solutions. The purpose of the team and the establishment of the best practice (BP) is to synchronize the industry together as a whole on a standardized OQ approach for the distribution of temperature-controlled pharmaceutical/biotech products. The goal is to have the principles described in this guidance be adopted by the entire pharmaceutical supply chain, including manufacturers, suppliers of passive thermal packaging, logistic service providers, carriers, wholesalers, distributors, specialty pharmacies, and any other interested party.Source: Healthcare Packaging