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:

To provide your commentsplease click the 'Review Now' button to access the document and comment form.  We are seeking feedback on specific items that your organization cannot comply with (and why), any missing details and/or content that needs further clarification.  We ask that you refrain from providing feedback around grammar and formatting. The deadline for comments has been extended until Monday March 28, 2022.

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For any questions, please email us at or call us at (517) 333-3437.


The ISTA Pharma Committee