A Cold Chain Process Validation Guide: Part 4: Component Qualification / Installment Qualification (CQ/IQ)
Robust test standards and test methods must be in place in your quality management...
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.
Robust test standards and test methods must be in place in your quality management...
read DetailsDeveloping mature quality systems is one of the biggest challenges and one of the...
read DetailsAre you aware of the open data files published online by the FDA? This...
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