Changes in CCIT testing have followed the evolution of regulatory guidance, and this article examines different possible CCIT strategy approaches. Container closure integrity (CCI) plays an important ...
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined. Container closure integrity (CCI) plays an ...
Quality Control (QC) instrumentation with common elements is important when needing to show evidence that the final product release for a sterile parenteral batch has met compliance with key shared ...
USP chapter <787>, Subvisible Particulate Matter in Therapeutic Protein Injections, became official August 1, 2014 and provides specific guidance for testing the final dose form of protein-based ...
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