The ISTA Pharma Committee is pleased to release their latest technical paper "ISTA PCG-02 Passive Thermal Packaging System Operational Qualification Best Practice Guideline". The committee's goal was to develop a guideline for the passive thermal packaging operational qualification process that defines the minimum requirements and drives standardization among packaging providers and life science companies alike.
Check out our Q&A here, and background on their USP Stimuli Article.
The new guideline is a result of a collaborative effort between life science companies and solution suppliers tasked with developing a set of mutually beneficial and harmonized requirements.
Call for Task Force Members
As a result of the virtual discussions over the summer, the ISTA Pharma Committee is forming task forces to develop best practice guidance on two key industry topics:
- Ambient Temperature Profiles (link to join)
- Performance Qualification/Verification (link to join)
The goal of the guidelines are to drive standardization of best practices for the benefit of both new and experienced professionals working in the temperature sensitive distribution industry.
ISTA's Pharma Committee is looking for industry professionals with experience in these two topics to become members of the task forces. If you are interested please click on the links next to bullets above.