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ISTA Pharma Committee Releases New Guidance Docs

One new document details best practice guidelines for performance qualification (PQ) and performance verification (PV) in thermal shipping systems, while the second offers a catalog listing and glossary of terms.

Ista Doc Pv Pq

Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline

The ISTA Pharma Committee is pleased to release the latest technical paper "ISTA PCG-03 | Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline." The committee's goal was to determine the various qualification/verification approaches medicinal product companies are following to implement and maintain compliant temperature-controlled shipping processes and develop a guideline to drive standardization of best practices across the industry. This collaborative effort between life science companies and solution providers resulted in a mutually beneficial and harmonized best practices guideline to aid the industry in implementing agile, compliant solutions.  

Catalog Listing & Glossary of Terms

In addition to this new best practice guideline, the ISTA Pharma Committee is also releasing “ISTA PCG-00 | Catalog Listing & Glossary of Terms.” This document provides a listing of all released guidance documents and serves as a centralized glossary that all guidance documentation will reference for common industry terms. The committee’s goal was to drive standardization among solution providers and life science companies alike and these terms were benchmarked with other industry association publications.

“The ISTA Pharma Committee and I are thrilled to see the collaborative effort culminate in tangible guidance that will bring value to the entire package testing community,” said Anthony Rizzo with Cold Chain Technologies, ISTA Pharma Committee Chair and member. “These guidance documents will define a representative standard and drive standardization to aid the industry in implementing agile, compliant solutions.”

Access all ISTA Pharma Committee developed best practice guidelines here.


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