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.
These subject matter experts (SMEs) released a USP Stimuli Article in March of 2019 entitled “Reusable Passive Thermal Packaging System: Best Practice Guideline.” The best practice provides specific guidance on the types of materials used in passive thermal packaging systems, the qualification of a reusable system, the return logistics and refurbishment service management, and refurbishment and inspection details. The demand for reusable packaging throughout the supply chain continues to grow for the following reasons:
- Opportunities for cost savings;
- Improved customer experience;
- Company sustainability goals;
- Receiving site’s in-country regulations;
- Cost-effective access to higher technology/performing systems;
- Receiving site’s intent to reuse the packaging system.
The increased demand for reusable passive thermal packaging systems has led to a wide variety of ways to qualify, return, refurbish, and manage these types of shipping solutions. Setting an industry best practice, as well as expectations for these aspects, will increase the quality of the systems and services and ultimately lead to increased product quality and solution innovation.
The group is currently drafting a “Passive Thermal Packaging System Operational Qualification Best Practice Guideline.” This best practice recognizes various Operational Qualification (OQ) approaches as well as already established industry-recognized guidance for the OQ process for passive thermal packaging solutions. This document will attempt to blend all of the different approaches into a single best practice guidance document and align the industry on a common approach. This will aid in developing a streamlined OQ approach for the qualification of passive thermal packaging solutions, support an industry alignment for vendor pre-qualified solutions and will improve the speed to market for these solutions.
