In-Process Controls (IPCs) for USP in cGMP

This activity presents In Process Controls (IPCs) in a USP context under cGMP, detailing their types, implementation methods, quality implications, as well as the PAT initiative and associated tools for enhanced process control.

This activity allows for hands-on practice of USP controls: verifying equipment compliance, assessing cell viability, identifying non-conforming results, checking sampling calculations, and ensuring sampling compliance.

This activity presents several real-life cases to analyze deviations or errors occurring during in-process controls in USP, identify the most appropriate course of action, and suggest improvement measures aligned with cGMP requirements.