No Temperature Controls Necessary For Small Molecules? Are You Sure?
Ensuring Quality for Small Molecule Therapy Supply Chains in a Growing Market Managing the...
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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.
Ensuring Quality for Small Molecule Therapy Supply Chains in a Growing Market Managing the...
read DetailsEnsuring the safe, effective delivery of small molecule drugs is more challenging than ever....
read DetailsAt a Glance: Cold Chain Engineering: Modality Solutions focuses on enhancing drug delivery through...
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