A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)
This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...
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.
This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...
read DetailsAre you aware of the open data files published online by the FDA? This...
read DetailsThis six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and...
read Details