Seeking Industry Peer Review of Thermal Shipping System PQ/PV Best Practice Guideline

ISTA Pharma Committee Best Practice Guideline Peer Review:
Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline

The ISTA Pharma Committee is seeking industry peer review on the latest best practice guideline "Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline".

This best practice guideline has been prepared by the ISTA Pharma Committee, which is composed of both life science manufacturers, wholesalers, and thermal packaging/monitoring suppliers. The process described is considered by this committee to represent current industry consensus on what a robust PQ/PV strategy should consider and how to incorporate these processes into the overall qualification of a thermal shipping system.  The goal is to have principles described in this guidance be adopted by the entire pharmaceutical supply chain, to harmonize/standardize the requirements that should be met when executing a PQ/PV on thermal shipping systems.
 
There are various industry guidance documents that discuss the “what” requirements for a PQ/PV.  However, there is very limited guidance for “how” to perform a PQ/PV.  This guidance document will bridge the current industry gap and provide a standardized approach that provides the requirements for how to perform a successful PQ/PV for thermal shipping systems.  The demand for process clarity when performing PQ/PV continues to grow for the following reasons/benefits:

• Accelerated implementation of thermal shipping systems
• Provide documented evidence that the thermal shipping system meets the end user requirements for the intended supply chain
• Determine an industry standard level of testing for PQ/PV
• Develop a minimum set of requirements for the execution of PQ/PV
• Reduce costs and resources associated with PQ/PV
• Industry alignment on compliance requirements

The ISTA Pharma Committee