Launching in the U.S.: FDA Transport Validation Compliance Essentials for European Manufacturers
Entering the U.S. market comes with a unique set of regulatory challenges, particularly when...
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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.
Entering 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...
read DetailsEnsuring Quality for Small Molecule Therapy Supply Chains in a Growing Market Managing the...
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