Empowering Functional VPs: Strategic Guidance for Sustainable Cold Chain Success
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsOn 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.
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read Details10 Common Misconceptions of Cold Chain Validation, as Explained by AI, commentary by Gary...
read DetailsGetting your vaccine or therapeutic approved by the FDA is a significant accomplishment. But...
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