Challenges and Benefits of Using ISTA’s Standard 20 for the Development of ISC’s
This article is written by Ed Church and Eric Hiser, President Emeritus, and Vice President at ISTA respectively:
ISTA Standard 20 Revision 2.0 is a process standard developed by pharma industry experts. It is a design and qualification process that applies the Quality-by-Design (QbD) approach. The structure and path to design, test, verify and independently certify a specific Insulated Shipping Container (ISC) for use is provided.
It sets the minimum requirements for qualifying insulated shippers and has been proven to develop shippers which meet regulatory expectations. Standard 20 contains full documentation, examples of protocol, qualification and data reports, full instructions and testing and reporting criteria. With Standard 20, ISTA reached a new level by not only setting the standard, but by providing a highly structured context in which to perform testing.
Source: Pharmaceutical Outsourcing