Part 1: The Foundation of Pharma Supply Chain Integrity
Introduction The integrity of supply chain management is pivotal in the demanding realm of...
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On July 22nd, 2022, ISTA released PCG-03: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline. PCG-03 takes the first steps toward standardizing best practices for PQ strategy and execution for the biopharmaceutical industry, as it is the first document to compile strategies from thought leaders in the industry and provide a path forward for transport validation work.
We applaud ISTA for this useful and comprehensive list of considerations for determining your PQ strategy. However, there remains a clear gap on how to manage and implement their recommendations. The items listed within the document require further context to enable the industry to form a cohesive approach to PQ strategy.
Introduction The integrity of supply chain management is pivotal in the demanding realm of...
read DetailsEntering the U.S. market comes with a unique set of regulatory challenges, particularly when...
read DetailsCompeting priorities, changing expectations, cost pressures, sustainability initiatives, and emerging markets are some of...
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